Gordian Robotic Integrated Port Closure Using the TroClose™ 1200 With the da Vinci® 12 mm Robotic Assistant Port
Gordian Surgical
Summary
The GRIP (Gordian Robotic Integrated Port Closure) Study is a prospective, single-arm feasibility study evaluating the use of the TroClose™ 1200 device for closure of da Vinci® 12 mm robotic assistant port sites following robotic-assisted surgical procedures. TroClose™ 1200 is an FDA-cleared medical device designed to facilitate fascial closure of laparoscopic and robotic access ports. The device deploys anchors and suture at the beginning of the procedure, allowing closure to be completed at the end of surgery without the need for additional needle passage or specialized closure instruments. The purpose of this study is to assess the safety, feasibility, procedural performance, and clinical outcomes associated with use of the device in patients undergoing robotic-assisted surgery. Study assessments will include successful port-site closure, device-related adverse events, post-operative complications, and short-term follow-up evaluations. Approximately 26 adult participants undergoing robotic-assisted surgical procedures at Allegheny Health Network will be enrolled.
Description
GRIP (Gordian Robotic Integrated Port Closure) is a prospective feasibility study evaluating the use of the TroClose™ 1200 device for closure of da Vinci® 12 mm robotic assistant port sites following robotic-assisted surgical procedures. TroClose™ 1200 is an FDA-cleared Class II medical device designed to facilitate fascial closure of laparoscopic and robotic access ports. The device deploys fixation anchors and suture during port insertion, allowing closure of the fascial defect at the completion of the procedure without the need for additional needle passage through the abdominal wall. This…
Eligibility
- Age range
- 18–95 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males or female patients age 18 to 95 years old * Scheduled to undergo an elective, clinically indicated robotic surgery with a da Vinci® 12 mm assistant port * Trocar site is appropriate for TroClose™ per Investigator/Surgeon discretion * Subject is able and willing to sign a written informed consent form Exclusion Criteria: * Scheduled to undergo emergency surgery * Weight under 45kg (99.2 pounds) * Infection at port site * Prior surgical mesh at intended incision location * Surgeon-determined contraindication for use of the TroClose™ 1200 * Inability to provide writ…
Interventions
- DeviceFascial closure device
* TroClose™ is inserted at the start of the procedure and anchors/sutures are deployed. * TroClose™ trocar is removed and replaced with a da Vinci® 12 mm port. * Sutures are tied at the end of the case.
Location
- AHN Allegheny General HospitalPittsburgh, Pennsylvania