None listed
Conditions
Brief summary
The aim of this study is to to assess the safety, usability and applicability of the ENDOGUARD™ laparoscopic safety device amongst advanced laparoscopic surgeons. Given the successful testing with cadavers, we hypothesise that this device would provide surgeons with the added confidence and security associated with the reduced risk of inadvertent intra-operative thermal and sharp injuries.
Interventions
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 throu
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.
Sponsors
Dr Bassem Gerges, SEABAS Enterprises Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women and gender diverse people aged 18 years and over scheduled for laparoscopic surgery.
Exclusion criteria
Nil
Outcome results
None listed