Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal

Overview

Colonoscopy parameters will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 2021

Detailed Description

Colonoscopy parameters such as demographics, findings and procedural times will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope

Interventions

  • Device: Standard Colonoscopy
    • Colonoscopy with a standard colonoscope
  • Device: G-EYE Colonoscopy
    • Colonoscopy with a G-EYE Colonoscope

Arms, Groups and Cohorts

  • Standard Colonoscopy
    • Colonoscopy with a standard colonoscope
  • G-EYE® Colonoscopy
    • Colonoscopy with a G-EYE Colonoscopy

Clinical Trial Outcome Measures

Primary Measures

  • Detection rate
    • Time Frame: February 2021
    • G-EYE® colonoscopy adenoma detection rate compared to adenoma detection rate of standard colonoscopy
  • Effectiveness of intervention
    • Time Frame: February 2021
    • G-EYE® colonoscopy polyp removal time compared to polyp removal time of standard colonoscopy

Participating in This Clinical Trial

Inclusion Criteria

  • Indication for screening or surveillance colonoscopy based on the German guideline for colon cancer screening Exclusion Criteria:

  • Emergency procedure – Patients with known inflammatory bowel diseases – Patients with hereditary cancer syndromes – Patients with acute colonic inflammation (e.g. diverticulitis, ischemic colitis) – Patients after radiation of the abdomen or pelvis – Patients with colonic surgery (except appendectomy) – Patients with incomplete colonoscopy – Patients with insufficient bowel preparation

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr. Horst Schmidt Klinik GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Ralf Kiesslich, Prof. – Dr. Horst Schmidt Klinik GmbH
  • Overall Official(s)
    • Ralf Kiesslich, Prof., Principal Investigator, Helios Dr. Horst Schmidt Kliniken Wiesbaden

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