Registry Evaluation of a Double Balloon Accessory Device

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

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 Overview

• Status: Unknown
• Conditions: Adenomatous Polyp of Colon
• Intervention / Treatment: Device: Double balloon accessory device

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Division of Gastroenterology, Hepatology and Nutrition
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Investigator's practice

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to perform the procedure safely and effectively with the study device.	Investigator answers yes or no	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach target lesion	Time measurement in hours and minutes	Intraoperatively
Time to remove lesion after intervention begins	Time measurement in hours and minutes	Intraoperatively
Total time using study device during case	Time measurement in hours and minutes	Intraoperatively
Total case time	Time measurement in hours and minutes	Intraoperatively
Total defect closure time	Time measurement in hours and minutes	Intraoperatively
User feedback on device performance	Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.	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.	Up to 30 days

Collaborators and Investigators

• Sponsor: Lumendi, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): March 31, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (ACTUAL): May 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps; Adenomatous Polyps
• Other Study ID Numbers: DD_20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes