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Disposable Sheathed Gastroscopic System for Cecal Intubation

A Novel Disposable Sheathed Gastroscopic System for Cecal Intubation:Safety and Efficacy in Unsedated Colonoscopies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02495480
Enrollment
120
Registered
2015-07-13
Start date
2015-07-31
Completion date
2015-12-31
Last updated
2015-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cecal Intubation Success Rate

Keywords

disposable sheath, intubation, colonoscopy

Brief summary

A novel disposable sheathed gastroscope system has been shown to be safe and more efficient in clinical practice during gastroscopy. This novel disposable sheathed endoscope system could effectively prevent cross-infection by simply taking off the contaminated sheath after examination of a patient and placing a new sheath on the endoscope. In this way, investigators can save the endoscopic reprocessing time and also decrease the need for endoscopic cleaning and disinfecting equipment. Participants may think that placing a new sheath on the endoscope can decrease the success rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on the endoscope during scope insertion can probably increases distension of the colonic lumen and loop formation. The probable adhesion may increase the discomfort of investigators and participants. But a previous clinical study by investigators' team showed that the participants' feeling were no significant difference (Z = -1.783, P = 0.075) between sheathed and conventional groups. No significant differences were observed in optical clarity, or pathology detection rate. There were no complications, and no microbial contamination was detected. Based on this study, investigators hypothesize that compared with conventional group, placing a new sheath on the endoscope does not significantly reduce the success rate of cecal intubation in average patients. The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the endoscope versus the conventional method in average participants. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.

Interventions

DEVICEA novel disposable sheath

a new sheath will be placed on the endoscope in sheathed group

Sponsors

Yuqi He
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* patients accepted sedated colonoscopy

Exclusion criteria

* a request for sedation/analgesia at the start of the procedure * previous colorectal surgery * declining to provide informed consent * advanced comorbidity * coagulopathy or anticoagulant medication administered * failure to comply with the recommended bowel preparation regimen.

Design outcomes

Primary

MeasureTime frame
Cecal intubation success rateup to ten months

Secondary

MeasureTime frame
Pain according to a 10-point pain scaleup to ten months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026