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Clinical Trials/NCT03942965
NCT03942965UnknownNot Applicable

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 enrollmentStarted: January 22, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
165
Locations
3
Primary Endpoint
Ability to perform the procedure safely and effectively with the study device.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Ability to perform the procedure safely and effectively with the study device.

Time Frame: Intraoperatively

Investigator answers yes or no

Secondary Outcomes

  • Number of Study Subjects with Treatment Related Adverse Events(Up to 30 days)
  • Time to reach target lesion(Intraoperatively)
  • Time to remove lesion after intervention begins(Intraoperatively)
  • Total time using study device during case(Intraoperatively)
  • Total case time(Intraoperatively)
  • Total defect closure time(Intraoperatively)
  • User feedback on device performance(Intraoperatively)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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