Robotic SurgeryGRIPNCT07649915
GRIP: Gordian Robotic Integrated Port Closure Study
A study testing Fascial closure device in people with Robotic Surgery, run by Gordian Surgical at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Robotic Surgery
- What is being tested?
- Fascial closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
James McCormick, DO, 412-687-7348, james.mccormick@ahn.org
Clinical Trials Contact, 412-687-7348, clinicaltrials@ahn.org
About this study
Official title: Gordian Robotic Integrated Port Closure Using the TroClose™ 1200 With the da Vinci® 12 mm Robotic Assistant Port
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Robotic Surgery
- Being tested
- Fascial closure device
- Keywords
- Robotic Surgery, Port Site Closure, Integrated Robotic Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial closure deviceDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional - TroClose1200 with DaVinci Robot | Experimental | This intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures. Receives: Device: Fascial closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (1)
Safety; Freedom from peri operative serious adverse events
serious adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gordian Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allegheny Health Network, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649915
- Sponsor's protocol ID
- AHN-GOR 001
- Acronym
- GRIP
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share data with other research groups now or in the future
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gordian Robotic Integrated Port Closure Using the TroClose™ 1200 With the da Vinci® 12 mm Robotic Assistant Port
- ClinicalTrials.gov ID
- NCT07649915
- Acronym / sponsor ID
- GRIP / AHN-GOR 001
- Conditions
- Robotic Surgery
- Keywords
- Robotic Surgery, Port Site Closure, Integrated Robotic Closure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Gordian SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- Allegheny Health Network, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional - TroClose1200 with DaVinci Robot | Experimental | Device: Fascial closure deviceThis intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Interventional - TroClose1200 with DaVinci Robot |
Primary outcome
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.
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.
1 secondary outcome
Safety; Freedom from peri operative serious adverse events
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to share data with other research groups now or in the future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial closure device in people with Robotic Surgery, run by Gordian Surgical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eddie Shaw (201 744 6062, eddie.shaw@gordiansurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.