AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Location contact
Clinical Trials Contact
CONTACT
James McCormick, DO
CONTACT
James McCormick, DO
PRINCIPAL_INVESTIGATOR
Richard Fortunato, DO
SUB_INVESTIGATOR
NCT Number: NCT07649915
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.
Trial opening soon.
Get Notified18 year–95 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15212, United States
Clinical Trials Contact
CONTACT
James McCormick, DO
CONTACT
James McCormick, DO
PRINCIPAL_INVESTIGATOR
Richard Fortunato, DO
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 days
Measured by confirmation of fascial closure by digital (finger) palpation - Measured as either closed or not closed.
Time frame: 30 days
Measured by confirmation of fascial closure by visual inspection - Measured as either closed or not closed.
Time frame: 30 days
serious adverse events
Contact information is provided by the study sponsor or research team.
Gordian Surgical
Industry
Gordian Robotic Integrated Port Closure Using the TroClose™ 1200 With the da Vinci® 12 mm Robotic Assistant Port
Acronym: GRIP
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.
Published trials that share one or more normalized conditions with this study.
NCT07710352
Body Weight, Digestive System Diseases
New York, United States
View Trial DetailsNCT07624916
Colonic Diseases, Colorectal Cancer
Taipei, Taiwan
View Trial DetailsNCT07591610
Robotic Surgery
Boston, Massachusetts, United States
View Trial DetailsNCT07541352
ColoRectal Cancer and Inflammatory Bowel Disease, Colonic Diseases
View Trial Details