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

NCT04767971 | Completed

• 1 other identifier: G-EYE
• Study Type: observational
• Target: 2,795
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adenoma; Colo-rectal Cancer

Keywords

Adenoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard Colonoscopy

Colonoscopy with a standard colonoscope

Device: Standard Colonoscopy

G-EYE® Colonoscopy

Colonoscopy with a G-EYE Colonoscopy

Device: G-EYE Colonoscopy

Interventions

Standard Colonoscopy DEVICE

Colonoscopy with a standard colonoscope

Standard Colonoscopy

G-EYE Colonoscopy DEVICE

Colonoscopy with a G-EYE Colonoscope

G-EYE® Colonoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Screening and surveillance colonoscopy patients

You may qualify if:

• \- Indication for screening or surveillance colonoscopy based on the German guideline for colon cancer screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (1)

Helios Dr. Horst Schmidt Kliniken

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Adenoma; Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ralf Kiesslich, Prof.

  Helios Dr. Horst Schmidt Kliniken Wiesbaden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)