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NCT Number: NCT07649915

GRIP: Gordian Robotic Integrated Port Closure Study

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.

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Key information

Conditions

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location contact

Clinical Trials Contact

CONTACT

[email protected]

412-687-7348

James McCormick, DO

CONTACT

[email protected]

412-687-7348

James McCormick, DO

PRINCIPAL_INVESTIGATOR

Richard Fortunato, DO

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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

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

  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

    Time frame: 30 days

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

Secondary outcomes

  1. Safety; Freedom from peri operative serious adverse events

    Time frame: 30 days

    serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Eddie Shaw

CONTACT

[email protected]

201 744 6062

Sponsors and collaborators

Lead sponsor

Gordian Surgical

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: GRIP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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