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

Colo-rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767971
• Other study ID #: G-EYE
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: October 2021
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2795
• Est. completion date: May 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colo-rectal Cancer

Intervention

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

Locations

Country	Name	City	State
Germany	Helios Dr. Horst Schmidt Kliniken	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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