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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Withdrawn

Conditions

Colorectal Neoplasms

Treatments

Device: Device Assisted Colonoscopy
Device: Standard Colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02504411
HSC-MS-12-0587

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups

Device Assisted Colonoscopy
Experimental group
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.
Treatment:
Device: Device Assisted Colonoscopy
Standard Colonoscopy
Active Comparator group
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.
Treatment:
Device: Standard Colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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