NCT03942965

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

May 3, 2019

Last Update Submit

December 10, 2020

Conditions

Adenomatous Polyp of Colon

Outcome Measures

Primary Outcomes (1)

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

    Investigator answers yes or no

    Intraoperatively

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Double balloon accessory deviceDEVICE

Double balloon accessory device is used during the endoscopic polypectomy procedure

Also known as: DiLumen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Investigator's practice

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Florida - Division of Gastroenterology, Hepatology and Nutrition

Gainesville, Florida, 32610, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Officials

  • Peter Draganov, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 8, 2019

Study Start

January 22, 2019

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

December 11, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)