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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02504411
• Other study ID #: HSC-MS-12-0587
• Status: Withdrawn
• Phase: N/A
• Start date: August 2015
• Est. completion date: February 15, 2017

Study information

• Verified date: August 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• Device Assisted Colonoscopy
This will be similar to the standard colonoscopy except the endocuff device will be used.
• Standard Colonoscopy
No endocuff device will be used on the study participants undergoing standard colonoscopy.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate (ADR) as determined by Colonoscopy		intraoperative
Primary	Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy		intraoperative
Secondary	Cecal Intubation Rate (CIR)		intraoperative