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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Polyp removal via ESD using standard of care
Polyp removal via ESD using GripTract
Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGTotal 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.
Time frame: Enrollment to 30 days
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.
Time frame: Enrollment to 30 days
Total Intervention Time
Total Intervention Time from the start of submucosal injection through the end of dissection.
Time frame: 4 hours
Dissection Time
Time from first incision of polyp removal (following circumferential incision) through end of polyp removal.
Time frame: 3 hours
Area of tissue removed
Dimensional measurement of resected tissue
Time frame: 4 hours
En bloc removal
Clinician peforming procedure provides a binary score: lesion removed en bloc, or lesion NOT removed en bloc
Time frame: 4 hours
Average Physician Feedback Score
Average score (Likert scale, 0-10) from seven different grading elements comparing the use of GripTract to the standard of care.
Time frame: 4 hours
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