This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.
Study Type
OBSERVATIONAL
Enrollment
165
Double balloon accessory device is used during the endoscopic polypectomy procedure
University of Florida - Division of Gastroenterology, Hepatology and Nutrition
Gainesville, Florida, United States
Geisinger Health System
Danville, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Ability to perform the procedure safely and effectively with the study device.
Investigator answers yes or no
Time frame: Intraoperatively
Time to reach target lesion
Time measurement in hours and minutes
Time frame: Intraoperatively
Time to remove lesion after intervention begins
Time measurement in hours and minutes
Time frame: Intraoperatively
Total time using study device during case
Time measurement in hours and minutes
Time frame: Intraoperatively
Total case time
Time measurement in hours and minutes
Time frame: Intraoperatively
Total defect closure time
Time measurement in hours and minutes
Time frame: Intraoperatively
User feedback on device performance
Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.
Time frame: Intraoperatively
Number of Study Subjects with Treatment Related Adverse Events
No moderate to severe mucosal injury, perforations or bleeding related to the use of the device.
Time frame: Up to 30 days
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