GRIP: Gordian Robotic Integrated Port Closure Study
ConditionRobotic Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorGordian Surgical
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Scheduled to undergo emergency surgery
Weight under 45kg (99.2 pounds)
Infection at port site
Prior surgical mesh at intended incision location
Trial design
Treatments tested in this trial
- Fascial closure device
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Gordian Surgical
Lead sponsor
Allegheny Health Network
Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborator
Source ClinicalTrials.gov