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

Completed

• Conditions: Colo-rectal Cancer; Adenoma
• Interventions: Device: Standard Colonoscopy; Device: G-EYE Colonoscopy

• Registration Number: NCT04767971
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

Brief Summary

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

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

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Primary Completion: 2021-04-01
• Study Completion: 2021-05-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2795

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard Colonoscopy	Standard Colonoscopy	Colonoscopy with a standard colonoscope
G-EYE® Colonoscopy	G-EYE Colonoscopy	Colonoscopy with a G-EYE Colonoscopy

Primary Outcome Measures

Name	Time	Method
Detection rate - measured by adenoma detection rate (% subjects having at least 1 adenoma)	February 2021	G-EYE® colonoscopy adenoma detection rate compared to adenoma detection rate of standard colonoscopy
Effectiveness of intervention - measured by polyp removal time (mm:ss)	February 2021	G-EYE® colonoscopy polyp removal time compared to polyp removal time of standard colonoscopy

Trial Locations

Locations (1)

Helios Dr. Horst Schmidt Kliniken; 🇩🇪 Wiesbaden, Germany