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

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

Study Overview

• Status: Completed
• Conditions: Adenoma; Colo-rectal Cancer
• Intervention / Treatment: Device: Standard Colonoscopy; Device: G-EYE Colonoscopy

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 Type: Observational
• Enrollment (Actual): 2795

Contacts and Locations

Study Locations

• Germany
  • Wiesbaden, Germany
    • Helios Dr. Horst Schmidt Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Screening and surveillance colonoscopy patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Colonoscopy; Colonoscopy with a standard colonoscope	Device: Standard Colonoscopy; Colonoscopy with a standard colonoscope
G-EYE® Colonoscopy; Colonoscopy with a G-EYE Colonoscopy	Device: G-EYE Colonoscopy; Colonoscopy with a G-EYE Colonoscope

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Adenoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: G-EYE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No