Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

Colorectal Canceer Clinical Trial

Official title:

Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02387593
• Other study ID #: END-1302-14/15-1
• Status: Unknown status
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 12, 2015
• Start date: September 2014

Study information

• Verified date: September 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: Rafael RB Barreto Zúñiga, MD
• Phone: 0155- 54870900
• Email: barretozu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 300
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenoma
• Colorectal Canceer

Intervention

Device:
• ENDOCUFF
One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline

Locations

Country	Name	City	State
Mexico	Rafael Barreto	México	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	Percentage of adenomas detected during colonoscopy	30 minutes
Primary	Measurement of the polyp detection rate	Percentage of polyps detected during colonoscopy	30 minutes
Secondary	Cecal intubation rate	Percentage of cecal intubation	30 minutes
Secondary	ileal intubation rate	Percentage of ileal intubation	10 minutes
Secondary	Difficulty performing polypectomy	When the endoscopist requiring special maneuvers to perform polypectomy	10 minutes
Secondary	Complications during colonoscopy	When patients require special handling during or immediately subsequent colonoscopy	One week