Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

Completed · Not applicable

Conditions studied: Colonic Adenomatous Polyps

In brief

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.

Key facts

Study ID

NCT02117232

Run by

Mercy Medical Center

People needed

216

Starts

2014-03-01

Expected to finish

2017-12-01

Last updated by the study team

2018-08-21

Who can join

Age: 17 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or for diagnostic workup.
• Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
• Age from 17 to 90 years.
• Be willing and able to comply with the requirements of the protocol.
• Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
• Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.

You may not qualify if…

• Subjects with a history of previous colonic resection.
• Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).
• Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
• Subjects with suspected colonic strictures potentially precluding complete colonoscopy.
• Subjects who received any experimental drug or device within the previous three months.
• Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
• Subjects who possessed any psychological condition, or were under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.

Where it is running

• Mercy Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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