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Recruiting
NCT06015607
Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon
Conditions: Polyps Colorectal
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Actuated Medical, Inc.
Location: Cleveland Clinic Cleveland Ohio
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
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
Source: ClinicalTrials.gov (NCT06015607). StuddyBuddy aggregates publicly available trial information.