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