GRIP: Gordian Robotic Integrated Port Closure Study

Conditions

• Robotic Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

• Fascial closure device — 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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Nov 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

26 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Interventional - TroClose1200 with DaVinci Robot
  This intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures.

Primary Outcome Measure

Technical Success; To determine the ability of the TroClose™ 1200 to achieve fascial closure when used with a 12mm da Vinci® robotic assistant port during robotic surgery [ Time Frame: 30 days ]

Central Contacts

• Eddie Shaw
  201 744 6062
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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