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Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Indiana University logo

Indiana University

Status

Completed

Conditions

Colorectal Adenoma
Colorectal Polyp
Colon Cancer

Treatments

Device: Endocuff Vision

Study type

Interventional

Funder types

Other

Identifiers

NCT03361917
1709336500

Details and patient eligibility

About

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

Full description

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Enrollment

200 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subject referred for a screening or surveillance colonoscopy
  • Subject is aged 40 years or older
  • Subject has the ability to provide informed consent

Exclusion criteria

  • Prior history of colon cancer
  • History of inflammatory bowel disease
  • Prior surgical resection of any part of the colon
  • Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
  • History of polyposis syndrome or HNPCC
  • Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer
  • Inability to provide informed consent

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Control Arm (Standard Colonscopy)
No Intervention group
Description:
Standard colonoscopy with no device attachments
Endocuff Vision
Experimental group
Description:
Colonoscopy with Endocuff Vision attached to distal end of scope
Treatment:
Device: Endocuff Vision

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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