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Registry Evaluation of a Double Balloon Accessory Device

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ClinicalTrials.gov Identifier: NCT03942965
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Adenomatous Polyp of Colon Device: Double balloon accessory device

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
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 22, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Device: Double balloon accessory device
    Double balloon accessory device is used during the endoscopic polypectomy procedure
    Other Name: DiLumen


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. Time to reach target lesion [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes

  2. Time to remove lesion after intervention begins [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes

  3. Total time using study device during case [ Time Frame: Intraoperatively ]
    Time measurement in hours and minutes

  4. Total case time [ 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942965


Contacts
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Contact: April Goddard, PA-C 352-273-9483 April.Goddard@medicine.ufl.edu
Contact: Beth Carson, RN; MA 844-481-0822 ext 107 beth.carson@lumendi.com

Locations
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United States, Florida
University of Florida - Division of Gastroenterology, Hepatology and Nutrition Recruiting
Gainesville, Florida, United States, 32610
Contact: April Goddard, PA-C    352-273-9483    April.Goddard@medicine.ufl.edu   
Sponsors and Collaborators
Lumendi, LLC
Investigators
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Principal Investigator: Peter Draganov, MD University of Florida

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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: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Adenomatous Polyps
Colonic Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical