NCT06152289

Brief Summary

Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2023Feb 2028

Study Start

First participant enrolled

February 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

June 6, 2023

Last Update Submit

February 27, 2026

Conditions

Bowel DiseaseCrohn DiseaseCeliac DiseaseChronic DiarrheaTumor

Keywords

Small bowelCapsule endoscopyArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Develop an artificial intelligence solution to help with diagnosis in VCE

    Sensitivity in detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

    Through study completion, 5 years

Secondary Outcomes (4)

  • Evaluation of the diagnostic performance of the A.I. solution in terms of detection

    Through study completion, 5 years

  • Evaluation of the diagnostic performance of the A.I. solution in terms of characterisation

    Through study completion, 5 years

  • Evaluation of the diagnostic performance of the A.I. solution in terms of recognition of anatomical landmarks

    Through study completion, 5 years

  • Evaluation of the diagnostic performance of the A.I. solution in terms of quality of preparation of the various segments of the digestive tract

    Through study completion, 5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient in whom a capsule endoscopy examination is performed as part of routine care

You may qualify if:

  • \- Any patient in whom a capsule endoscopy examination is performed as part of routine care.

You may not qualify if:

  • \- Opposition to the use of images and videos from daily, routine care for research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Endoscopie Digestive Hôpital Saint-Antoine

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Intestinal DiseasesCrohn DiseaseCeliac DiseaseNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesGastroenteritisMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Xavier DRAY, MD PhD

CONTACT

+33 (0) 49 28 21 60Xavier.dray@aphp.fr

Romain LEENHARDT, MD

CONTACT

+33 (0) 1 49 28 21 61romain.leenhardt@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

November 30, 2023

Study Start

February 10, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

FR(1)