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

RecruitingNAAges 21 Years - anyAllActuated Medical, Inc.
NCT06015607 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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?

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📋 Eligibility rules (as published)
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
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What it tests

  • Control (via ESD using standard of care)
  • GripTract
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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