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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard of care for removal of polyps during endoscopic submucosal disection (ESD). |
|
| GripTract | Experimental | GripTract Endoscopic Tissue Manipulator will be installed on the endoscope and used to assist with removal of polyps during endoscopic submucosal disection (ESD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control (via ESD using standard of care) | Device | Polyp removal via ESD using standard of care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Enrollment to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Intervention Time | Total Intervention Time from the start of submucosal injection through the end of dissection. | 4 hours |
| Dissection Time | Time from first incision of polyp removal (following circumferential incision) through end of polyp removal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emre Gorgun, MD | Contact | 1-800-223-2273 | gorgune@ccf.org | |
| Rita Brienza | Contact | 1-800-223-2273 | brienzr@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Emre Gorgun, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| GripTract |
| Device |
Polyp removal via ESD using GripTract |
|
| 3 hours |
| Area of tissue removed | Dimensional measurement of resected tissue | 4 hours |
| En bloc removal | Clinician peforming procedure provides a binary score: lesion removed en bloc, or lesion NOT removed en bloc | 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. | 4 hours |