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Registry Evaluation of a Double Balloon Accessory Device

NCT ID: NCT03942965

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-22

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenomatous Polyp of Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Double balloon accessory device

Double balloon accessory device is used during the endoscopic polypectomy procedure

Intervention Type DEVICE

Other Intervention Names

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DiLumen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lumendi, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Draganov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida - Division of Gastroenterology, Hepatology and Nutrition

Gainesville, Florida, United States

Site Status

Geisinger Health System

Danville, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DD_20

Identifier Type: -

Identifier Source: org_study_id