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

Sponsor
Dr. Horst Schmidt Klinik GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT04767971
Collaborator
(none)
2,795
Enrollment
1
Location
14
Actual Duration (Months)
199.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
2795 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helios Dr. Horst Schmidt Kliniken Wiesbaden Germany

Sponsors and Collaborators

  • Dr. Horst Schmidt Klinik GmbH

Investigators

  • Principal Investigator: Ralf Kiesslich, Prof., Helios Dr. Horst Schmidt Kliniken Wiesbaden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Ralf Kiesslich, Prof., Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier:
NCT04767971
Other Study ID Numbers:
  • G-EYE
First Posted:
Feb 23, 2021
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Dr. Ralf Kiesslich, Prof., Dr. Horst Schmidt Klinik GmbH
Adenoma
Colorectal Cancer
Additional relevant MeSH terms:
Adenoma

Study Results

No Results Posted as of Oct 22, 2021