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Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

NCT02117232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2018-08-21

No results posted yet for this study

Summary

Colonoscopy has become the "gold standard" in detection of colonic polyps and colon cancer. However, colonoscopy causes significant abdominal discomfort and abdominal pain during and after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and pain are mostly caused by air insufflation and intubation difficulties during advancement of the colonoscope in order the reach the cecum.

Study Hypothesis: Use of the "Visualization" Balloon will facilitate advancement of the colonoscope and will eliminate the need for colonic distention with the air or CO2, which can shortened the length of the procedure, reduce patient's discomfort and can decrease amount of sedatives and analgesics used during colonoscopy.

Conditions

  • Colonic Adenomatous Polyps

Interventions

DEVICE

Visualization balloon

The "Visualization" Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the "Visualization" Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The "Visualization" Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The "Visualization" Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon.

DEVICE

Traditional CO2 insufflation colonoscopy

Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

Sponsors & Collaborators

  • Mercy Medical Center

    lead OTHER

Principal Investigators

  • Sergey V Kantsevoy, MD, PhD · Mercy Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117232 on ClinicalTrials.gov