GRIP: Gordian Robotic Integrated Port Closure Study (GRIP)

Gordian Robotic Integrated Port Closure Using the TroClose™ 1200 With the da Vinci® 12 mm Robotic Assistant Port

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Robotic Surgery
• Intervention / Treatment: Device: Fascial closure device

Detailed 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 approach is intended to provide a standardized and reproducible closure technique while minimizing additional procedural steps at the conclusion of surgery.

Robotic surgery continues to expand across multiple surgical specialties, resulting in increased utilization of 12 mm robotic assistant ports. Appropriate closure of fascial defects associated with larger trocar sites remains an important consideration for reducing port-site complications and maintaining procedural efficiency. The GRIP study is designed to evaluate the performance of a pre-positioned closure system within the robotic surgical environment.

Participants undergoing eligible robotic-assisted surgical procedures will receive closure of a designated da Vinci® 12 mm assistant port using the TroClose™ 1200 device according to the study protocol. The study will assess device utilization within routine clinical practice and characterize procedural performance, workflow integration, and safety outcomes associated with use of the device in robotic-assisted surgery.

Data generated through this investigation will contribute to the understanding of pre-positioned fascial closure techniques for robotic surgery and may inform future clinical studies, publications, and broader adoption of robotic port-site closure technologies.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eddie Shaw; Phone Number: 201 744 6062; Email: eddie.shaw@gordiansurgical.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • AHN Allegheny General Hospital
      • Principal Investigator: James McCormick, DO
      • Contact: James McCormick, DO; Phone Number: 412-687-7348; Email: james.mccormick@ahn.org
      • Contact: Clinical Trials Contact; Phone Number: 412-687-7348; Email: clinicaltrials@ahn.org
      • Sub-Investigator: Richard Fortunato, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional - TroClose1200 with DaVinci Robot; This intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety; Freedom from peri operative serious adverse events	serious adverse events	30 days

Collaborators and Investigators

• Sponsor: Gordian Surgical
• Collaborators: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Allegheny Health Network

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Robotic Surgery; Port Site Closure; Integrated Robotic Closure
• Other Study ID Numbers: AHN-GOR 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share data with other research groups now or in the future

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No