Usefulness of Endocuff in the Adenoma Detection Rate. Com... | NCT02387593

Studies
Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

NCT02387593

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Unknown status

Last Update Posted

Mar 13, 2015Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Colorectal Canceer

Interventions

ENDOCUFF

Countries

Mexico

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2015Estimated

Completion Date

Not provided

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Mar 12, 2015

First Posted Date

Mar 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

Mar 12, 2015

Last Update Posted Date

Mar 13, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Rafael Barreto Zúñiga, Attached to the Department of Endoscopy Medical Institute, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPrincipal Investigator

Lead Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranOTHER

Collaborators

Not provided

Description Module

Brief Summary

Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.

The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.

The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.

There is insufficient evidence of the usefulness of endocuf

Detailed Description

All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
colonoscopy with endocuff	Experimental	To the usual colonoscopy will place a endocuff at the tip of the colonoscope	Device: ENDOCUFF
standard colonoscopy without endocuff	No Intervention	Routine colonoscopy without endocuff

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENDOCUFF	Device	One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline	colonoscopy with endocuff

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	Percentage of adenomas detected during colonoscopy	30 minutes
Measurement of the polyp detection rate	Percentage of polyps detected during colonoscopy	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Cecal intubation rate	Percentage of cecal intubation	30 minutes
ileal intubation rate	Percentage of ileal intubation	10 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult patients,
Aged 18,
Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies

Exclusion Criteria:

Boston colonic preparation <5 points
Suspected Lynch syndrome or familial adenomatous polyposis (FAP)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rafael RB Barreto Zúñiga, MD	Contact	0155- 54870900	2150	barretozu@yahoo.com
Rafael Rafael, MD	Contact	0155-54870900	2150	barretozu@yahoo.com

Overall Officials

Name	Affiliation	Role
Rafael Rafael, MD	Department of Endoscopy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rafael Barreto	Recruiting	México	Tlalpan	14000	Mexico

Type	Date	Date Unknown
Release	Feb 23, 2016
Reset	Mar 24, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 23, 2016			Mar 24, 2016

Condition Browse Module

MeSH Terms

ID	Term
D000236	Adenoma

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided