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Trial registered on ANZCTR


Registration number
ACTRN12613000128796
Ethics application status
Approved
Date submitted
31/01/2013
Date registered
1/02/2013
Date last updated
2/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A new surgical system for use in the treating patients who have chronic rhinosinusitis (CRS) and have elected to undergo sinus surgery.
Scientific title
A 12 week randomized within-participant controlled, open-treatment, multi-center study to assess the safety and efficacy of a low heat light based tissue dissection versus standard surgical technique for anterior ethmoidectomy and/or turbinate reduction during Functional Endoscopic Sinus Surgery (FESS) for chronic rhinosinusitis participants.
Secondary ID [1] 281857 0
OPEL-001
Universal Trial Number (UTN)
U1111-1138-9945
Trial acronym
OPEL-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Endoscopic Sinus Surgery (FESS) 288220 0
chronic rhinosinusitis (CRS) 288221 0
Condition category
Condition code
Surgery 288585 288585 0 0
Surgical techniques
Respiratory 288586 288586 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 288613 288613 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study have chronic rhinosinusitis (CRS) that is not controlled by medical treatment. It is important to remember that participants would have been offered Functional Endoscopic Sinus Surgery (FESS) surgery for the treatment of CRS, regardless of whether this new laser was available or not.

The intervention treatment is the PLS Opel Surgical System is a compact solid state surgical laser system.

In this within-participant controlled study, each participant will receive investigational treatment and conventional surgical instruments to one sinus and conventional surgical instruments alone to the other sinus. The surgeon will decide which conventional instruments to use and how much laser is required during the surgery.

Participants will be treated in day surgery. The total time of surgery will depend on the type of FESS needed, but is anticipated to be under 1 hour. The time of surgery and time using the investigational treatment will be measured in minutes.

Intervention code [1] 286414 0
Treatment: Surgery
Intervention code [2] 286440 0
Treatment: Devices
Comparator / control treatment
Participants in this study have chronic rhinosinusitis (CRS) that is not controlled by medical treatment. It is important to remember that participants would have been offered Functional Endoscopic Sinus Surgery (FESS) surgery for the treatment of CRS, regardless of whether this new laser was available or not.

The control treatment is the conventional surgical instruments.

In this within-participant controlled study, each participant will receive investigational treatment and conventional surgical instruments to one sinus and conventional surgical instruments alone to the other sinus. The surgeon will decide which conventional instruments to use and how much laser is required during the surgery.

Participants will be treated in day surgery. The total time of surgery will depend on the type of FESS needed, but is anticipated to be under 1 hour. The time of surgery and time using the conventional surgical instruments will be measured in minutes.
Control group
Active

Outcomes
Primary outcome [1] 288740 0
Safety:
Measured from the adverse events noted in the Intention to Treat (ITT) and Surgical populations. The adverse event data will be
reported in number and frequency of events.

The known risks of FESS surgery are:
Bleeding – most sinus surgery involves some degree of blood loss; almost all patients will experience a small amount of bleeding. Some patients require nasal packing that requires removal the next day. A blood transfusion because of bleeding is rarely necessary (0.75% or less than 1 in 100) and would only be undertaken if your health was at risk.

Return of chronic sinusitis (10% to 20%; or a 1 in 10 to 1 in 5 chance) - although FESS surgery has been shown to provide significant benefits for patients suffering from chronic sinusitis, surgery is not a cure for the disease. A wide range of recurrence has been reported in other studies after sinus surgery using standard instruments, although the likelihood of recurrence is largely influenced by how severe the condition was at the time of the original surgery. Nevertheless, patients can expect to continue with sinus medication even after successful sinus surgery, although the amount of medication should in general be less.

Cerebrospinal fluid leak (0.17% or less than 1 in 100 chance) - because the sinuses are so close to the brain, there is a rare chance that surgery can cause a leak of the fluid lining the brain or injury the brain. Cerebrospinal fluid leak has never occurred with turbinate reduction but may occur when FESS is conducted in the upper part of the sinuses. If left untreated, the complications from this could be meningitis which is an inflammation of the membranes of the brain and the spinal cord. If a cerebrospinal leak were to occur, additional surgery might be required to close this.

Visual problems (0.07% or less than 1 in 100 chance) – there have been some reports of vision being lost after FESS surgery but there have been no reports of visual loss associated with turbinate reduction. The changes of recovering lost vision are not good. This complication is fortunately very rare. Double vision has also been reported following sinus surgery. Constant tearing or watering from one or both eyes can also result from this surgery but this resolves on its own.

Other risks of sinus surgery in general include the following:
Change in sense of smell or taste
Continued and/or worsening of sinus symptoms and facial pain
Swelling or bruising of the area around the eyes
Voice changes
Numbness to the teeth/cheek
Reactions to anaesthesia including unexpected heart, lung or kidney changes
Need for frequent post-surgical visits for cleaning to help prevent the disease from returning and/or need for future medical/surgical care

Risks specific to the OPEL Surgical System may include thermal injury to the tissue being treated (estimated at less than 1 in 100).

Timepoint [1] 288740 0
From surgery to End Of Study (EOS) at 12 weeks.
Primary outcome [2] 288742 0
Device Performance:
The proportion of surgeons classifying the conventional surgical instruments plus Opel surgical procedure as “Easier than usual” or “Much easier than usual” as noted on the 5-point Likert scale of ease of use / surgery, and reported as the frequency and percentage .
Timepoint [2] 288742 0
Surgery visit
Secondary outcome [1] 300882 0
Visualization of surgical field:
Measured on a 5-point likert scale and reported as the frequency and percentage for each treatment arm.
Timepoint [1] 300882 0
Surgery Visit
Secondary outcome [2] 300883 0
Mucosal tissue cutting ability and speed:
Measured on a 5-point likert scale and reported as the frequency and percentage for each treatment arm.
Timepoint [2] 300883 0
Surgery Visit
Secondary outcome [3] 300884 0
Bone cutting ability and speed:
Measured on a 5-point likert scale and reported as the frequency and percentage for each treatment arm.
Timepoint [3] 300884 0
At Surgery Visit
Secondary outcome [4] 300885 0
Intraoperative blood loss:
Measured on a 5-point likert scale and reported as the frequency and percentage for each treatment arm.
The likert scale for the intraoperative blood loss is
0 = Very severe, 1 = Severe, 2 = Moderate, 3= Mild, 4 = None
Timepoint [4] 300885 0
At Surgery Visit
Secondary outcome [5] 300886 0
surgical site healing:
Measured on a visual analogue scale (0=No site healing - 10 completely healed) and reported with the descriptive statistics for each treatment arm.
Timepoint [5] 300886 0
From surgery to End Of Study (EOS) at 12 weeks.
Secondary outcome [6] 300887 0
Surgery time:
Measured in minutes for each treatment arm and reported with descriptive statistics.
Timepoint [6] 300887 0
At Surgery Visit

Eligibility
Key inclusion criteria
Male or female participant

Aged between 18 to 70 years inclusive

Are free of any disease or physical condition which might, in the investigator’s opinion, expose the participant to an unacceptable risk by study participation;

Abnormal CT scan indicative of CRS;

Clinical signs and symptoms present at screening of CRS including headache, facial pain, facial pressure, congestion, and/or post-nasal drip;

Documented history of CRS (polypoid or non-polypoid), suggestive of inflammation and infection for at least 90 consecutive days prior to the Screening Visit, who have failed conventional medical therapy for the condition;

Bilaterally similar disease in the right and left anterior ethmoid sinuses and/or turbinates as determined by the study investigator;

Clinically indicated for anterior ethmoidectomy and/or turbinate reduction during FESS as determined by the study investigator;

Agreement to follow the study requirements and restrictions including attending all visits and permitting all required assessments.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women of childbearing potential who are pregnant and/or lactating,

Participants unlikely to comply with protocol procedures or adhere to the study visit schedule;

Previous turbinate and/or anterior ethmoidectomy surgical procedures; (Please Note If participant is scheduled for turbinate surgery, they must not have had previous turbinate surgical procedures, however they can have had previous anterior ethmoidectomy surgical procedures. Note: if participant is scheduled for anterior ethmoidectomy surgical procedures, they must not have had previous anterior ethmoidectomy surgical procedures however they can have had prior turbinate surgical procedures).

Any medical condition that in the opinion of the investigator might jeopardize the participant’s safety and/or cause ineligibility to undergo FESS, including, but not limited to:

Major surgery within 30 days prior to the Screening Visit, or planned surgery during the study period;

Diagnosed bleeding disorders, such as hemophilia,

Ongoing regimens of anti-coagulants (e.g., warfarin), medications (e.g. NSAIDs), vitamins (e.g. high doses vitamin E or C), herbal remedies (e.g. gingko biloba, ginseng, St. John’s Wort) or other substances (e.g. excessive amounts of garlic) known to increase coagulation time within 14 days prior to the Randomization/Surgery Visit at Day 0.

Donation of blood/plasma and/or any significant blood loss for any reason greater than 450 ml within 30 days prior to Screening Visit, or during the study period;

Concurrent enrollment in another investigational drug or device study; or use of any experimental or investigational drug or device within 30 days, or for drugs within 6 times the elimination half-life, if that is longer, prior to the Screening Visit;

Any condition rendering a participant unable to understand the nature, scope, and possible consequences of the study or study procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Before recruitment and enrollment, each prospective candidate will be given a full explanation of the study and be allowed to read the approved informed consent form and have any questions asked and answered. Once the investigator is assured that the individual understands the implications of participating in the study, the individual will be asked to give consent to participate in the study by signing the informed consent form.

Upon determining a subject’s eligibility status, the subject will be offered the opportunity to participate in the study, and the will be given a unique screening identifier number subject’s initials will be entered into the study site’s screening log. If the subject undergoes surgery they will additionally be assigned a unique subject identifier in addition to their unique screening identifier.

The statistician will prepare a randomization schedule assigning study and control treatments to the left or right side of the sinuses for each participant. The randomization schedule will be balanced to achieve a right/left treatment distribution ratio of approximately 1:1 among participants. The study investigator will randomize the left/right assignment for each participant immediately prior to surgery on Day 0. Allocation is not concealed, and the participant and surgeon will be aware of which sinus the laser was used in addition to conventional surgical instruments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistician will prepare a randomization schedule using a simple randomisation table created by computerised sequence generation software. The statistician will assign study and control treatments to the left or right side of the sinuses for each participant. The randomization schedule will be balanced to achieve a right/left treatment distribution ratio of approximately 1:1 among participants. The study investigator will randomize the left/right assignment for each participant immediately prior to surgery on Day 0. Allocation is not concealed, and the participant and surgeon will be aware of which sinus the laser was used in addition to conventional surgical instruments.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A randomized (1:1) within-participant controlled. All participants will undergo anterior ethmoidectomy and/or turbinate reduction via FESS using conventional surgical instruments (CSI) to one side of the sinuses and CSI plus the PLS Opel Surgical System (OPEL) to the opposite side of the sinuses. Right and left surgical procedures performed with conventional surgical instruments or conventional surgical instruments plus the PLS Opel Surgical System will be randomized prior to surgery. Allocation is not concealed, and the participant and surgeon will be aware of which sinus the laser was used in addition to conventional surgical instruments.
The two arms of the study are:
Surgery Arm A: Right sinus CSI+OPEL & Left Sinus CSI.
Surgery Arm B: Right sinus CSI & Left Sinus CSI+OPEL
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistical analyses will be performed for all study endpoints. Given the exploratory nature of this study, additional analyses may be conducted. These analyses will be described in detail in the final statistical report. Summary statistics will include counts and percentages for categorical variables and the number of participants, mean, standard deviation (SD), median, minimum, and maximum for continuous variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 509 0
St Luke's Hospital - Potts Point
Recruitment hospital [2] 511 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 512 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [4] 513 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [5] 514 0
Cotham Private Hospital - Kew
Recruitment hospital [6] 516 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment hospital [7] 517 0
Warringal Private Hospital - Heidelberg
Recruitment postcode(s) [1] 6251 0
2011 - Potts Point
Recruitment postcode(s) [2] 6252 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 6253 0
2113 - Macquarie Park
Recruitment postcode(s) [4] 6254 0
3101 - Cotham
Recruitment postcode(s) [5] 6255 0
3084 - Heidelberg
Recruitment postcode(s) [6] 12152 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 286639 0
Commercial sector/Industry
Name [1] 286639 0
Precise Light Surgical
Address [1] 286639 0
310 W. Hamilton Avenue, Suite 210
Campbell, CA 95008
Country [1] 286639 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Five Corners
Address
13/76 Reserve Road, Artarmon NSW 2064
Country
Australia
Secondary sponsor category [1] 285422 0
Commercial sector/Industry
Name [1] 285422 0
Precise Light Surgical
Address [1] 285422 0
310 W. Hamilton Avenue, Suite 210
Campbell, CA 95008
Country [1] 285422 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288715 0
St Vincent's Hospital HREC
Ethics committee address [1] 288715 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 288715 0
Australia
Date submitted for ethics approval [1] 288715 0
26/09/2012
Approval date [1] 288715 0
04/12/2012
Ethics approval number [1] 288715 0
AU/1/734F012

Summary
Brief summary
The current standard of practice for the treatment of CRS includes antibiotics either given by mouth or through an injection in your arm, nasal sprays and rinses, oral and nasal corticosteroids and/or anti-allergy medicines. Despite these treatments some patients are still unable to get relief from their sinus symptoms.

When the above treatments fail and the disease continues then some patients will move forward to surgery. This type of surgery is called “Functional Endoscopic Sinus Surgery (FESS)”. The surgery is quite difficult and requires great surgical skill. One of the problems associated with FESS surgery is making sure that the area being treated is clear of blood so the surgeon can see the area he is treating. There are a number of complications associated with bleeding with this type of surgery which your doctor will explain to you. A potential solution to try and improve the visibility when performing FESS surgery is to use laser throughout the procedure.

Laser is used in many types of surgery, including surgery for ears, nose and the throat (otolaryngology). The laser being tested during this study is a new laser. It has been designed so that it delivers the laser through a much smaller fibre (a tube that delivers the light to the tissue) and also uses very low power to avoid unwanted damage to nearby healthy tissue, which will hopefully help achieve better results from surgery and also fewer complications with this type of surgery.

This study is being done to look at the safety and the performance of this new laser when it is used during FESS procedures. It is important to remember that you would have undergone the surgery regardless of this new laser – the new laser is an additional treatment being used during the procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37410 0
A/Prof Richard Harvey
Address 37410 0
Sydney Ear Nose and Throat
354 Victoria Street Darlinghurst
NSW 2010
Country 37410 0
Australia
Phone 37410 0
+61 2 9360 4811
Fax 37410 0
+61 2 9360 4811
Email 37410 0
richard@sydneyentclinic.com
Contact person for public queries
Name 37411 0
Ms Jenna Christensen
Address 37411 0
Sydney Ear Nose & Throat Clinic
354 Victoria Street
DARLINGHURST NSW 2010
Country 37411 0
Australia
Phone 37411 0
+61 2 9360 4811
Fax 37411 0
+61 2 9360 9919
Email 37411 0
jenna@sydneyentclinic.com
Contact person for scientific queries
Name 37412 0
Ms Jenna Christensen
Address 37412 0
Sydney Ear Nose & Throat Clinic
354 Victoria Street
DARLINGHURST NSW 2010
Country 37412 0
Australia
Phone 37412 0
+61 2 9360 4811
Fax 37412 0
+61 2 9360 9919
Email 37412 0
jenna@sydneyent.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary