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?
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
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
Parallel
Control (via ESD using standard of care)
DevicePolyp removal via ESD using standard of care
GripTract
DevicePolyp removal via ESD using GripTract
Total Number of Device-Attributable Major Adverse Events
Subjects will receive follow-ups at 24 hrs, 72 hours, and 30 days post intervention to monitor adverse events. Major adverse events are those that necessitate non-endoscopic intervention.
Total Number of Device-Attributable Minor Adverse Events
Subjects will receive follow-ups at 24 hrs, 72 hrs, and 30 days post intervention to monitor adverse events. Minor adverse events are those that can be successfully addressed endoscopically.
Total Intervention Time
Total Intervention Time from the start of submucosal injection through the end of dissection.
Dissection Time
Time from first incision of polyp removal (following circumferential incision) through end of polyp removal.
Area of tissue removed
Dimensional measurement of resected tissue
En bloc removal
Clinician peforming procedure provides a binary score: lesion removed en bloc, or lesion NOT removed en bloc
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Actuated Medical, Inc.
Lead sponsor
National Institutes of Health (NIH)
Collaborator
