Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies
This is a prospective cohort study to investigate the performance of the test instrument.
The test instrument consists of a slim, flexible colonoscope with an overtube and an
inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are
eligible for inclusion if conventional colonoscopy fails due to technical difficulties such
as loop formation, long colonic segments or suspected adhesions. Written informed consent is
required. The study procedures will be performed immediately after the failed conventional
colonoscopy, or on a rescheduled appointment within four weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Cecal intubation rate
The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.
Michael Bretthauer, PhD
The Cancer Registry of Norway, Oslo University Hospital
Norway: Regional Ethics Commitee