Polyps Colorectal
Conditions
Keywords
endoscopic submucosal dissection
Brief 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?
Interventions
DEVICEControl (via ESD using standard of care)
Polyp removal via ESD using standard of care
DEVICEGripTract
Polyp removal via ESD using GripTract
Sponsors
Actuated Medical, Inc.
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Device-Attributable Major Adverse Events | Enrollment to 30 days | 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 | Enrollment to 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Intervention Time | 4 hours | Total Intervention Time from the start of submucosal injection through the end of dissection. |
| Dissection Time | 3 hours | Time from first incision of polyp removal (following circumferential incision) through end of polyp removal. |
| Area of tissue removed | 4 hours | Dimensional measurement of resected tissue |
| En bloc removal | 4 hours | Clinician peforming procedure provides a binary score: lesion removed en bloc, or lesion NOT removed en bloc |
| Average Physician Feedback Score | 4 hours | Average score (Likert scale, 0-10) from seven different grading elements comparing the use of GripTract to the standard of care. |
Countries
United States
Contacts
CONTACTEmre Gorgun, MD
CONTACTRita Brienza
PRINCIPAL_INVESTIGATOREmre Gorgun, MD
The Cleveland Clinic
Outcome results
None listed