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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Registry Evaluation of a Double Balloon Accessory Device

  • Clinicaltrials.gov identifier

    NCT03942965

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 8, 2019

  • Last update posted

    December 11, 2020

Study Description

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.

  • Condition or Disease:Adenomatous Polyp of Colon
  • Intervention/Treatment: Device: Double balloon accessory device
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational [Patient Registry]
  • Actual Enrollment: 165 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: March 2021

Outcome Measures

  • Primary Outcome Measures: 1. Ability to perform the procedure safely and effectively with the study device. [ Time Frame: Intraoperatively ]
    Investigator answers yes or no
  • Secondary Outcome Measures: 1. Total time using study device during case [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes
  • 2. Total case time [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes
  • 3. Time to reach target lesion [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes
  • 4. Time to remove lesion after intervention begins [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes
  • 5. Total defect closure time [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes
  • 6. User feedback on device performance [ Time Frame: Intraoperatively ]
    Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.
  • 7. Number of Study Subjects with Treatment Related Adverse Events [ Time Frame: Up to 30 days ]
    No moderate to severe mucosal injury, perforations or bleeding related to the use of the device.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Investigator's practice

Criteria

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

Contacts and Locations

Contacts

Locations

United States, Florida
University of Florida - Division of Gastroenterology, Hepatology and Nutrition
Gainesville

United States, Pennsylvania
Geisinger Health System
Danville

United States, Texas
Baylor College of Medicine
Houston

Sponsors and Collaborators

Lumendi, LLC

Investigators

Principal Investigator: Peter Draganov, MD University of Florida

More Information

  • Responsible Party: Lumendi, LLC
  • ClinicalTrials.gov Identifier: NCT03942965 History of Changes
  • Other Study ID Numbers: DD_20
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: December 11, 2020
  • Last Verified: December 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • 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
  • Additional relevant MeSH terms: Adenomatous Polyps Colonic Polyps