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| Name | Class |
|---|---|
| Allegheny Health Network | OTHER |
| Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | OTHER |
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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.
TroCloseâ„¢ 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.
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.
TroCloseâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional - TroClose1200 with DaVinci Robot | Experimental | This intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fascial closure device | Device |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety; Freedom from peri operative serious adverse events | serious adverse events | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eddie Shaw | Contact | 201 744 6062 | eddie.shaw@gordiansurgical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHN Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
There is no plan to share data with other research groups now or in the future
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