Disposable Sheathed Gastroscopic System for Cecal Intubation | NCT02495480

Studies
Disposable Sheathed Gastroscopic System for Cecal Intubation

NCT02495480

Sponsor

Yuqi He

Status

Unknown status

Last Update Posted

Jul 13, 2015Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Cecal Intubation Success Rate

Interventions

A novel disposable sheath

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 6, 2015

First Submission Date that Met QC Criteria

Jul 10, 2015

First Posted Date

Jul 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2015

Last Update Posted Date

Jul 13, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuqi He, Doctor, General Hospital of Beijing PLA Military RegionSponsor-Investigator

Lead Sponsor

Yuqi HeOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sheathed group	Experimental	The sterilized disposable sheath covered the outer surface of the colonoscope, then colonoscope will be performed in conventional way;a new sheath will be placed on the endoscope in sheathed group as a intervention	Device: A novel disposable sheath
conventional group	No Intervention	Colonoscopy will be performed with air insufflation during insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A novel disposable sheath	Device	a new sheath will be placed on the endoscope in sheathed group	sheathed group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cecal intubation success rate		up to ten months

Secondary Outcomes

Measure	Description	Time Frame
Pain according to a 10-point pain scale		up to ten months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided