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GRIP: Gordian Robotic Integrated Port Closure Study

NCT07649915 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • Robotic Surgery

Interventions

DEVICE

Fascial 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.

Sponsors & Collaborators

  • Allegheny Health Network

    collaborator OTHER

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    collaborator OTHER

  • Gordian Surgical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-11-30
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649915 on ClinicalTrials.gov