Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.

Lumendi, LLC3 sites in 1 country165 target enrollmentJanuary 22, 2019

ConditionsAdenomatous Polyp of Colon

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adenomatous Polyp of Colon
Sponsor: Lumendi, LLC
Enrollment: 165
Locations: 3
Primary Endpoint: Ability to perform the procedure safely and effectively with the study device.
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 22, 2019

End Date

March 31, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Lumendi, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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