Registry Evaluation of a Double Balloon Accessory Device

Adenomatous Polyp of Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03942965
• Other study ID #: DD_20
• Status: Active, not recruiting
• Start date: January 22, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2020
• Source: Lumendi, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyp of Colon
• Adenomatous Polyps
• Colonic Polyps

Intervention

Device:
• Double balloon accessory device
Double balloon accessory device is used during the endoscopic polypectomy procedure

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania
United States	University of Florida - Division of Gastroenterology, Hepatology and Nutrition	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lumendi, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to perform the procedure safely and effectively with the study device.	Investigator answers yes or no	Intraoperatively
Secondary	Time to reach target lesion	Time measurement in hours and minutes	Intraoperatively
Secondary	Time to remove lesion after intervention begins	Time measurement in hours and minutes	Intraoperatively
Secondary	Total time using study device during case	Time measurement in hours and minutes	Intraoperatively
Secondary	Total case time	Time measurement in hours and minutes	Intraoperatively
Secondary	Total defect closure time	Time measurement in hours and minutes	Intraoperatively
Secondary	User feedback on device performance	Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.	Intraoperatively
Secondary	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.	Up to 30 days