Health TrialsbyHealthPanel

GRIP: Gordian Robotic Integrated Port Closure Study

ConditionRobotic Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorGordian Surgical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Scheduled to undergo emergency surgery

Weight under 45kg (99.2 pounds)

Infection at port site

Prior surgical mesh at intended incision location

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Interventional - TroClose1200 with DaVinci RobotExperimental treatment 1 intervention

Trial outcomes

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

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

Time frame
30 days
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

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

Time frame
30 days

Secondary outcomes

1

Safety; Freedom from peri operative serious adverse events

serious adverse events

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gordian Surgical

Lead sponsor

Allegheny Health Network

Collaborator

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

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: