Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625001118493p
Ethics application status
Submitted, not yet approved
Date submitted
8/09/2025
Date registered
13/10/2025
Date last updated
13/10/2025
Date data sharing statement initially provided
13/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The ENDOGUARD™ Pilot Study: Evaluating a Novel Safety Device for Women and gender diverse adults undergoing Laparoscopic Surgery
Scientific title
The ENDOGUARD™ Pilot Study: Evaluating a Novel Device Outcomes for Guarding Users Against Risk of Damage in Laparoscopic Surgery
Secondary ID [1] 315337 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Surgery 338817 0
Condition category
Condition code
Surgery 335110 335110 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patented ENDOGUARD™ laparoscopic safety device has been developed to provide a temporary platform within the surgical cavity to cover and protect underlying tissue, organs and structures at laparoscopic surgery. The ENDOGUARD™ consists of a flexible, silicone-based membrane that provides insulation against thermal and penetrative injuries. Following insertion of the required ports, the sterilised device pre-rolled into the trocar which is inserted through an 11mm port and easily pushed through with the included plunger.. The ENDOGUARD is then positioned appropriately at the surgical site, and following completion of the procedure, prior to removal of the ports under vision, the membrane is easily removed through the same port using the attached ribbon.

The surgeons will then complete a questionnnaire assessing the safety, usability and applicability of the device.
Intervention code [1] 331938 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342744 0
To assess the safety, usability and applicability of the ENDOGUARD™ laparoscopic safety device amongst advanced laparoscopic surgeons. These will be assessed as a composite outcome.
Timepoint [1] 342744 0
Surgeon questionnaires will be completed immediately following completion of the surgery.
Secondary outcome [1] 451970 0
Monitoring and recording of any adverse outcomes or complications. The possible adverse outcomes could include obsucring of the surgical view or retention of device fragments and subsequent infection risks.
Timepoint [1] 451970 0
The questionnaires will be completed immediately folloiwng completion of the surgery.

Eligibility
Key inclusion criteria
Women and gender diverse people aged 18 years and over scheduled for laparoscopic surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Categorical variables will be presented as percentages and continuous ones as means with standard deviations (SD). Baseline and clinical data will be compared using nonparametric tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28445 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 28447 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 44674 0
2148 - Blacktown
Recruitment postcode(s) [2] 44676 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 319917 0
Commercial sector/Industry
Name [1] 319917 0
SEABAS ENTERPRISES PTY LTD
Country [1] 319917 0
Australia
Primary sponsor type
Individual
Name
Dr Bassem Gerges, SEABAS Enterprises Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 322444 0
Individual
Name [1] 322444 0
Dr Sean Heinz, SEABAS Enterprises Pty Ltd
Address [1] 322444 0
Country [1] 322444 0
Australia
Secondary sponsor category [2] 322511 0
Individual
Name [2] 322511 0
SEABAS ENTERPRISES PTY LTD
Address [2] 322511 0
Country [2] 322511 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318462 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 318462 0
Ethics committee country [1] 318462 0
Australia
Date submitted for ethics approval [1] 318462 0
08/09/2025
Approval date [1] 318462 0
Ethics approval number [1] 318462 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144274 0
Dr Bassem Gerges
Address 144274 0
Norwest Obstetrics & Gynaecology, Suite 4.12, The Bond, 8 Elizabeth Macarthur Drive, Bella Vista NSW 2153
Country 144274 0
Australia
Phone 144274 0
+61288835143
Fax 144274 0
Email 144274 0
[email protected]
Contact person for public queries
Name 144275 0
Dr Bassem Gerges
Address 144275 0
Norwest Obstetrics & Gynaecology, Suite 4.12, The Bond, 8 Elizabeth Macarthur Drive, Bella Vista NSW 2153
Country 144275 0
Australia
Phone 144275 0
+61288835143
Fax 144275 0
Email 144275 0
[email protected]
Contact person for scientific queries
Name 144276 0
Dr Bassem Gerges
Address 144276 0
Norwest Obstetrics & Gynaecology, Suite 4.12, The Bond, 8 Elizabeth Macarthur Drive, Bella Vista NSW 2153
Country 144276 0
Australia
Phone 144276 0
+61288835143
Fax 144276 0
Email 144276 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Aside from Age, BMI and Surgery performed, there will be no specific participant data collected. The surgeon questionnaire focuses on the safety, usability and applicability of the ENDOGUARD™ device.



What supporting documents are/will be available?



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.