CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 214 enrolled
Drug / intervention
CO2 insufflation regulator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01758900
NCT01758900Phase 4Completed

CO2 Versus Air Insufflation for Single-balloon Enteroscopy: a Randomized, Controlled Trial

Zhizheng Ge·interventional·Posted Jan 1, 2013·Updated Nov 25, 2016

In Brief

A Phase 4 clinical trial evaluating CO2 insufflation regulator and Air insufflation for Intubation Depth. Completed, enrolled 214 participants across 1 site.

Detailed Summary

Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small intestine.Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy) examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 1, 2013
Enrollment StartJul 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.5 years ago

Interventions

CO2 insufflation regulatordevice

The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.

Air insufflationdevice

The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.