Registry Evaluation of a Double Balloon Accessory Device

• Conditions: Adenomatous Polyp of Colon

• Registration Number: NCT03942965
• Lead Sponsor: Lumendi, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

1. Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
2. Patients capable of giving informed consent in English
3. No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection

Exclusion Criteria

1. No patients less than 18 years of age.
2. Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture)
3. History of open or laparoscopic colorectal surgery
4. History of Inflammatory Bowel Disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability to perform the procedure safely and effectively with the study device.	Intraoperatively	Investigator answers yes or no

Secondary Outcome Measures

Name	Time	Method
Number of Study Subjects with Treatment Related Adverse Events	Up to 30 days	No moderate to severe mucosal injury, perforations or bleeding related to the use of the device.
Time to reach target lesion	Intraoperatively	Time measurement in hours and minutes
Time to remove lesion after intervention begins	Intraoperatively	Time measurement in hours and minutes
Total time using study device during case	Intraoperatively	Time measurement in hours and minutes
Total case time	Intraoperatively	Time measurement in hours and minutes
Total defect closure time	Intraoperatively	Time measurement in hours and minutes
User feedback on device performance	Intraoperatively	Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.

Trial Locations

Locations (3)

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