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Trial record 8 of 19 for:    colon cancer | ( Map: Mexico )

Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

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ClinicalTrials.gov Identifier: NCT02387593
Recruitment Status : Unknown
Verified September 2014 by Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was:  Recruiting
First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE March 13, 2015
Last Update Posted Date March 13, 2015
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • Adenoma detection rate [ Time Frame: 30 minutes ]
    Percentage of adenomas detected during colonoscopy
  • Measurement of the polyp detection rate [ Time Frame: 30 minutes ]
    Percentage of polyps detected during colonoscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • Cecal intubation rate [ Time Frame: 30 minutes ]
    Percentage of cecal intubation
  • ileal intubation rate [ Time Frame: 10 minutes ]
    Percentage of ileal intubation
  • Difficulty performing polypectomy [ Time Frame: 10 minutes ]
    When the endoscopist requiring special maneuvers to perform polypectomy
  • Complications during colonoscopy [ Time Frame: One week ]
    When patients require special handling during or immediately subsequent colonoscopy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study
Official Title  ICMJE Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Colorectal Canceer
Intervention  ICMJE Device: ENDOCUFF
One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline
Study Arms  ICMJE
  • Experimental: colonoscopy with endocuff
    To the usual colonoscopy will place a endocuff at the tip of the colonoscope
    Intervention: Device: ENDOCUFF
  • No Intervention: standard colonoscopy without endocuff
    Routine colonoscopy without endocuff
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02387593
Other Study ID Numbers  ICMJE END-1302-14/15-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Sponsor  ICMJE Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rafael Rafael, MD Department of Endoscopy
PRS Account Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP