A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

NCT ID: NCT05869838

Last Updated: 2024-12-03

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

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-12

Study Completion Date

2025-06-30

Brief Summary

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The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

Detailed Description

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The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices. The data will be collected during routine colonoscopy procedures. Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. The histopathological results will be recorded.

Conditions

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Colonic Polyp

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Colonoscopy

Screening or surveillance colonoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years or older
* Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
* Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam

Exclusion Criteria

* Patients for whom endoscopic submucosal dissection is planned
* Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
* Patients who have to receive an urgent colonoscopy procedure
* Patients who underwent total colectomy of the large intestine
* Patients who are judged by a physician to be contraindicated for colonoscopy procedures
* Patients who have participated in another clinical study within the last 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympus Europe SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sofía Parejo Carbonell

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Locations

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End- und Dickdarmzentrum Hannover

Hanover, , Germany

Site Status COMPLETED

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Ersta Hospital Stockholm

Stockholm, , Sweden

Site Status WITHDRAWN

Countries

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Germany Spain Sweden

Central Contacts

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Swaantje Hoffstedt

Role: CONTACT

+49 40 23773 9351

Facility Contacts

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NA NA

Role: primary

Other Identifiers

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2023-001

Identifier Type: -

Identifier Source: org_study_id