Back to resultsOutcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy
Primary Purpose
Colorectal Neoplasms
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device Assisted Colonoscopy
Standard Colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing first screening colonoscopy
- Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.
- Ability to provide informed consent.
Exclusion Criteria:
- Previous surgical resection of any part of the colon
- history of colon cancer
- history of inflammatory bowel disease
- use of antiplatelet agents or anti-coagulants that precluded removal of polyps
- Poor general condition
- History of polyposis syndrome or hereditary nonpolyposis colorectal cancer
- Inability to give informed consent.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Device Assisted Colonoscopy
Standard Colonoscopy
Arm Description
Device assisted colonoscopy (DAC) is a technique of attaching disposable devices like "Endocuff" or "Transparent cap" at tip of colonoscope to improve mucosal visualization and stability.
Standard colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a camera on a flexible tube passed through the anus.
Outcomes
Primary Outcome Measures
Adenoma detection rate (ADR) as determined by Colonoscopy
Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy
Secondary Outcome Measures
Cecal Intubation Rate (CIR)
Full Information
NCT ID
NCT02504411
First Posted
July 20, 2015
Last Updated
August 9, 2018
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02504411
Brief Title
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy
Official Title
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy Versus Standard Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Funding was not secured
Study Start Date
August 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device Assisted Colonoscopy
Arm Type
Experimental
Arm Description
Device assisted colonoscopy (DAC) is a technique of attaching disposable devices like "Endocuff" or "Transparent cap" at tip of colonoscope to improve mucosal visualization and stability.
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Standard colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a camera on a flexible tube passed through the anus.
Intervention Type
Device
Intervention Name(s)
Device Assisted Colonoscopy
Intervention Description
This will be similar to the standard colonoscopy except the endocuff device will be used.
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
No endocuff device will be used on the study participants undergoing standard colonoscopy.
Primary Outcome Measure Information:
Title
Adenoma detection rate (ADR) as determined by Colonoscopy
Time Frame
intraoperative
Title
Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Cecal Intubation Rate (CIR)
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing first screening colonoscopy
Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.
Ability to provide informed consent.
Exclusion Criteria:
Previous surgical resection of any part of the colon
history of colon cancer
history of inflammatory bowel disease
use of antiplatelet agents or anti-coagulants that precluded removal of polyps
Poor general condition
History of polyposis syndrome or hereditary nonpolyposis colorectal cancer
Inability to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirav Thosani, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy
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