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

NCT ID: NCT04767971

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2795 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-05-01

Brief Summary

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

Detailed Description

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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

Conditions

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Adenoma Colo-rectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Standard Colonoscopy

Colonoscopy with a standard colonoscope

Standard Colonoscopy

Intervention Type DEVICE

Colonoscopy with a standard colonoscope

G-EYE® Colonoscopy

Colonoscopy with a G-EYE Colonoscopy

G-EYE Colonoscopy

Intervention Type DEVICE

Colonoscopy with a G-EYE Colonoscope

Interventions

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Standard Colonoscopy

Colonoscopy with a standard colonoscope

Intervention Type DEVICE

G-EYE Colonoscopy

Colonoscopy with a G-EYE Colonoscope

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Horst Schmidt Klinik GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Prof. Dr. Ralf Kiesslich

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Kiesslich, Prof.

Role: PRINCIPAL_INVESTIGATOR

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Locations

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Helios Dr. Horst Schmidt Kliniken

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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G-EYE

Identifier Type: -

Identifier Source: org_study_id