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Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon
Sponsor: Actuated Medical, Inc.
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?
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-06-11
Completion Date
2027-08
Last Updated
2026-06-15
Healthy Volunteers
No
Conditions
Interventions
Control (via ESD using standard of care)
Polyp removal via ESD using standard of care
GripTract
Polyp removal via ESD using GripTract
Locations (1)
Cleveland Clinic
Cleveland, Ohio, United States