"Effectiveness and Safety of the Colonoscopy With Visualization Balloon"

NACompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

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"

Trial Locations (1)

21202

Mercy Medical Center, Baltimore

Sponsors
All Listed Sponsors
lead

Mercy Medical Center

OTHER