GripTract GI Endoscopic Tissue Manipulator for complex colon polypectomies
Official title: Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon
Run by Actuated Medical, Inc. · NCT06015607 · Data updated 2026-11-12
This study tests the GripTract device to see if it is safer and more effective than the current method for removing complex colon polyps in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Actuated Medical, Inc. Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | June 11, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT06015607 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for endoscopic removal of suspected adenomatous polyps without contraindications to colonoscopy or endoscopic mucosal/ submucosal dissection.
✕Probably not a fit
Patients with polyps that are not complex or those who do not derive advantage from device-assisted manipulation may not experience added benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares the GripTract GI Endoscopic Tissue Manipulator to the standard care used during complex polypectomies in the colon. Adults scheduled for removal of suspected adenomatous polyps are randomized to receive either the GripTract-assisted procedure or the conventional endoscopic submucosal dissection approach. Outcomes focus on device-related adverse events, procedure time, en bloc resection capability, and user feedback on device performance. The trial is led by Actuated Medical, Inc. with NIH collaboration and is conducted at Cleveland Clinic. Eligibility includes adults without contraindications to colonoscopy, and excludes those under 21 or with inflammatory bowel disease or prior colorectal surgery, among other criteria.
Why it matters
Potential benefit: If successful, GripTract could reduce complications and shorten procedure times for complex polypectomies.
How similar studies have gone: Previous device-assisted endoscopic methods have shown promise in improving precision and safety for complex resections, but this exact device- and indication-specific approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s) * Patients capable of giving informed consent English and lacking cognitive impairment * No medical contraindication to endoscopic mucosal resection or endoscopic submucosal dissection Exclusion Criteria: * Patients less than 21 years of age * Any contraindication to colonoscopy with due to subject's colon anatomy (i.e., structure) * History of open or laparoscopic colorectal surgery * History of Inflammatory Bowel Disease * Patients requiring multiple polyp removals
Where it's running
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Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Emre Gorgun, MD — The Cleveland Clinic
- Study coordinator: Emre Gorgun, MD
- Email: gorgune@ccf.org
- Phone: 1-800-223-2273
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.