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

NCT02504411 | Withdrawn FDA Device

• 1 other identifier: HSC-MS-12-0587
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Adenoma detection rate (ADR) as determined by Colonoscopy

  intraoperative

• Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy

  intraoperative

Secondary Outcomes (1)

• Cecal Intubation Rate (CIR)

  intraoperative

Study Arms (2)

Device Assisted Colonoscopy

EXPERIMENTAL

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

Standard Colonoscopy

ACTIVE COMPARATOR

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

Interventions

Device Assisted Colonoscopy DEVICE

This will be similar to the standard colonoscopy except the endocuff device will be used.

Device Assisted Colonoscopy

Standard Colonoscopy DEVICE

No endocuff device will be used on the study participants undergoing standard colonoscopy.

Standard Colonoscopy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nirav Thosani, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 21, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 15, 2017
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

US (1)