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

Condition(s) studied

Investigational drug(s) / intervention(s)

Control (via ESD using standard of care): Polyp removal via ESD using standard of care

GripTract: Polyp removal via ESD using GripTract

Study 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?

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)