NCT06015607NARecruiting

Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon

Actuated Medical, Inc.

Start Date

6/11/2026

Completion Date

8/1/2027

Summary

The goal of this clinical trial is to compare the safety and effectiveness of the GripTract GI Endoscopic Tissue Manipulator to the current standard of care for complex polypectomies in adults. The main questions it aims to answer are: 1. How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care? 2. How is the procedure time affected? 3. Is the ability to resect the tissue en bloc affected? 4. What is the user feedback on the device performance?

Eligibility Criteria

Age Range: 21 years to No maximum

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

Interventions

DEVICE

Control (via ESD using standard of care)

DEVICE

GripTract

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Conditions

Polyps Colorectal

Locations

Cleveland Clinic

Cleveland, Ohio 44195

United States