|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
23 March 2015 |
|
Main ID: |
NCT02387593 |
|
Date of registration:
|
09/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study
|
|
Scientific title:
|
Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial |
|
Date of first enrolment:
|
September 2014 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT02387593 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Rafael Barreto, MD |
|
Address:
|
|
|
Telephone:
|
54870900 |
|
Email:
|
barretozu@yahoo.com |
|
Affiliation:
|
|
|
|
Name:
|
Rafael RB Barreto Zúñiga, MD |
|
Address:
|
|
|
Telephone:
|
0155- 54870900 |
|
Email:
|
barretozu@yahoo.com |
|
Affiliation:
|
|
|
|
Name:
|
Rafael Rafael, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Endoscopy |
|
|
Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Colorectal Canceer
|
|
Intervention(s)
|
|
Device: ENDOCUFF
|
|
Primary Outcome(s)
|
|
Adenoma detection rate
[Time Frame: 30 minutes]
|
|
Measurement of the polyp detection rate
[Time Frame: 30 minutes]
|
|
Secondary Outcome(s)
|
|
ileal intubation rate
[Time Frame: 10 minutes]
|
|
Complications during colonoscopy
[Time Frame: One week]
|
|
Difficulty performing polypectomy
[Time Frame: 10 minutes]
|
|
Cecal intubation rate
[Time Frame: 30 minutes]
|
|
Secondary ID(s)
|
|
END-1302-14/15-1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|