Back to resultsSafety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.
Primary Purpose
Adenomatous Polyps
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EndoCuff-assisted colonoscopy
Standard Colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenomatous Polyps
Eligibility Criteria
Inclusion Criteria:
- Colonoscopy: Screening , Surveillance, Diagnostic
Exclusion Criteria:
- Pregnancy
- age<18 years
- age > 80 years
- known colonic strictures
- chronic inflammatory bowel disease
- active inflammation
Sites / Locations
- University of Naples Federico II
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endocuff assisted Colonoscopy
Standard Colonoscopy
Arm Description
Endocuff assisted Colonoscopy
Standard colonoscopy
Outcomes
Primary Outcome Measures
adenoma detection rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02374515
Brief Title
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.
Official Title
Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Naples
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.
Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endocuff assisted Colonoscopy
Arm Type
Active Comparator
Arm Description
Endocuff assisted Colonoscopy
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Standard colonoscopy
Intervention Type
Device
Intervention Name(s)
EndoCuff-assisted colonoscopy
Other Intervention Name(s)
EC-assisted colonoscopy
Intervention Description
Adenoma detection rate
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Primary Outcome Measure Information:
Title
adenoma detection rate
Time Frame
20 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colonoscopy: Screening , Surveillance, Diagnostic
Exclusion Criteria:
Pregnancy
age<18 years
age > 80 years
known colonic strictures
chronic inflammatory bowel disease
active inflammation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni D. De Palma, MD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.
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