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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04378660
Other study ID # s59405
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2019
Est. completion date April 18, 2020

Study information

Verified date April 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy


Description:

This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.


Recruitment information / eligibility

Status Completed
Enrollment 357
Est. completion date April 18, 2020
Est. primary completion date April 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

- > 18 years

- Diagnostic or screening colonoscopy

- Therapeutic colonoscopy

Exclusion Criteria:

- Inability to give informed consent by the patient or legal representative

- < 18 years old

- Any contraindication for colonoscopy or biopsies of the colon

- Uncontrolled coagulopathy

- Confirmed diagnosis of inflammatory bowel disease

- Short bowel or ileostomy

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Artificial intelligence for polyp detection
Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven Vlaams-Brabant

Sponsors (3)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Nuovo Regina Margherita Hospital, Rome, Italy, Universitäts Medizin, Mainz, Germany

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard Determination of the diagnostic accuracy of the novel AI system as second observer 4 months
Secondary Endoscopist's polyp miss rate as number of extra AI detections Determination of the AI system's precision and extra value as second observer 4 months
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