A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Indiana University

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Device: Standard Colonoscopy; Device: FUSE® Colonoscopy; Device: Colonoscopy with EndoRings™; Device: Colonoscopy with EndoCuff™

Study type: Interventional

Funder types: Other

Identifiers

NCT02345889

1412036333

Details and patient eligibility

About

Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure

Full description

Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

Enrollment: 1,262 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Screening or Surveillance Colonoscopy

Exclusion criteria

• Personal history of Colorectal cancer or Inflammatory bowel disease
• Surgical resection of the colon or known colonic stricture
• Personal or family history of Polyposis syndromes or Lynch syndrome
• Referral for incomplete colonoscopy or known therapeutic polyp clearance
• Severe diverticular disease
• Referral for a positive hemoccult test in the past 6 months
• Known coagulopathy
• Inability to provide informed consent

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,262 participants in 4 patient groups

FUSE® Colonoscopy

Active Comparator group

Description:

A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy

Treatment:

Device: FUSE® Colonoscopy

Colonoscopy with EndoCuff™

Active Comparator group

Description:

An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope

Treatment:

Device: Colonoscopy with EndoCuff™

Colonoscopy with EndoRings™

Active Comparator group

Description:

An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope

Treatment:

Device: Colonoscopy with EndoRings™

Standard Colonoscopy

Active Comparator group

Description:

A standard colonoscope will be used to complete the procedure

Treatment:

Device: Standard Colonoscopy