Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02504411
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.5
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Device: Device Assisted Colonoscopy; Device: Standard Colonoscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy Versus Standard Colonoscopy
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device Assisted Colonoscopy 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.	Device: Device Assisted Colonoscopy; This will be similar to the standard colonoscopy except the endocuff device will be used.
Active Comparator: Standard Colonoscopy 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.	Device: Standard Colonoscopy; No endocuff device will be used on the study participants undergoing standard colonoscopy.

Outcome Measures

Primary Outcome Measures

1. Adenoma detection rate (ADR) as determined by Colonoscopy [intraoperative]

2. Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy [intraoperative]

Secondary Outcome Measures

1. Cecal Intubation Rate (CIR) [intraoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Patients undergoing first screening colonoscopy

2. Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.

3. Ability to provide informed consent.

Exclusion Criteria:

1. Previous surgical resection of any part of the colon

2. history of colon cancer

3. history of inflammatory bowel disease

4. use of antiplatelet agents or anti-coagulants that precluded removal of polyps

5. Poor general condition

6. History of polyposis syndrome or hereditary nonpolyposis colorectal cancer

7. Inability to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Nirav Thosani, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nirav C Thosani, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT02504411
• Other Study ID Numbers: HSC-MS-12-0587
• First Posted: Jul 21, 2015
• Last Update Posted: Aug 13, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Aug 13, 2018