GRIP: Gordian Robotic Integrated Port Closure Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• 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 [Срок оценки: 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 [Срок оценки: 30 days]

Вторичные конечные точки (1)

• Safety; Freedom from peri operative serious adverse events [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• AHN Allegheny General Hospital — Pittsburgh

Идентификаторы

NCT: NCT07649915 · AHN-GOR 001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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