EndoRings Colonoscopy vs Standard Colonoscopy

Indiana University

Status: Completed

Conditions: Colorectal Adenoma; Colorectal Polyp; Colon Cancer

Treatments: Device: EndoRings device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03418662

1711224972

Details and patient eligibility

About

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Full description

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Enrollment: 592 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Screening or Surveillance Colonoscopy
• Able to provide written informed consent

Exclusion criteria

• Known narrow colon or colon stenosis
• Personal history of Colorectal cancer
• History of inflammatory bowel disease
• Familial adenomatous polyposis syndrome (FAP)
• Hyperplastic polyposis syndrome
• Referral for incomplete colonoscopy or polyp clearance

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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592 participants in 2 patient groups

Control Arm (Standard Colonoscopy)

No Intervention group

Description:

Standard colonoscopy with no device attachment.

EndoRings Colonoscopy

Experimental group

Description:

Colonoscopy with EndoRings device attached to the distal end of the scope.

Treatment:

Device: EndoRings device