Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.

Overview

This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.

Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

Full Title of Study: “Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

Interventions

  • Device: EndoCuff-assisted colonoscopy
    • Adenoma detection rate
  • Device: Standard Colonoscopy

Arms, Groups and Cohorts

  • Active Comparator: Endocuff assisted Colonoscopy
    • Endocuff assisted Colonoscopy
  • Active Comparator: Standard Colonoscopy
    • Standard colonoscopy

Clinical Trial Outcome Measures

Primary Measures

  • adenoma detection rate
    • Time Frame: 20 min.

Participating in This Clinical Trial

Inclusion Criteria

  • Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion Criteria

  • Pregnancy
  • age<18 years
  • age > 80 years
  • known colonic strictures
  • chronic inflammatory bowel disease
  • active inflammation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Naples
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giovanni Domenico De Palma, Full Professor of Surgery – Federico II University
  • Overall Official(s)
    • Giovanni D. De Palma, MD, Principal Investigator, Federico II University

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