NCT02387593

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

March 13, 2015

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

March 9, 2015

Last Update Submit

March 12, 2015

Conditions

Colorectal Canceer

Keywords

AdenomaColonoscopyScreening

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • Cecal intubation rate

    30 minutes

  • ileal intubation rate

    10 minutes

  • Difficulty performing polypectomy

    10 minutes

  • Complications during colonoscopy

    One week

Study Arms (2)

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

ENDOCUFFDEVICE

One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline

colonoscopy with endocuff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafael Barreto

México, Tlalpan, 14000, Mexico

RECRUITING

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Rafael Rafael, MD

    Department of Endoscopy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael RB Barreto Zúñiga, MD

CONTACT

0155- 54870900barretozu@yahoo.com

Rafael Rafael, MD

CONTACT

0155-54870900barretozu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attached to the Department of Endoscopy Medical Institute

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 13, 2015

Study Start

September 1, 2014

Primary Completion

April 1, 2015

Last Updated

March 13, 2015

Record last verified: 2014-09

Locations

ME(1)