GRIP: Gordian Robotic Integrated Port Closure Study

NCT07649915 | Not Yet Recruiting FDA Device

• 1 other identifier: AHN-GOR 001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Robotic Surgery; Port Site Closure; Integrated Robotic Closure

Outcome Measures

Primary Outcomes (2)

• 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

  Measured by confirmation of fascial closure by digital (finger) palpation - Measured as either closed or not closed.

  30 days

• 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

  Measured by confirmation of fascial closure by visual inspection - Measured as either closed or not closed.

  30 days

Secondary Outcomes (1)

• Safety; Freedom from peri operative serious adverse events

  30 days

Study Arms (1)

Interventional - TroClose1200 with DaVinci Robot

EXPERIMENTAL

This intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures.

Device: Fascial closure device

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.

Interventional - TroClose1200 with DaVinci Robot

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 written, informed consent
• Known allergy to PGA (Polyglycolic Acid)
• PLA (Polylactic Acid).

Sponsors & Collaborators

• Gordian Surgical: lead
• Allegheny Health Network: collaborator
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): collaborator

Study Sites (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Central Study Contacts

Eddie Shaw

CONTACT

201 744 6062; eddie.shaw@gordiansurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 16, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)