Development of New Diagnostic Tools in Capsule Endoscopy

Trial Title: Development of New Diagnostic Tools in Capsule Endoscopy

NCT ID: NCT06152289

Condition: Bowel Disease
Crohn Disease
Celiac Disease
Chronic Diarrhea
Tumor

Conditions: Official terms:
Crohn Disease
Celiac Disease
Diarrhea

Conditions: Keywords:
Small bowel
Capsule endoscopy
Artificial intelligence

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Detailed description: Capsule endoscopy is a minimally-invasive diagnostic procedure based on the ingestion (or endoscopic delivery) of a miniaturized biocompatible, camera. Capsules capture tenths of thousands images of the digestive tract. Reading the captured images and reporting is long, tedious, and at risk of errors when the reader's attention is disturbed. Artificial intelligence is expected to alleviate these limitations, by both improving diagnostic performances of capsule endoscopy while reducing reading time. Any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study. Their de-identified images and videos will be extracted, thus allowing the creation of several databases for training, tuning and testing technological bricks of artificial intelligence. Basic clinical data will be collected (age, gender, indication for capsule endoscopy, type of device, ingestion or delivery of capsule). Images and videos will be characterized centrally and consensually by a panel of 3 expert readers, according to their level of relevance in relation to the type and indication of capsule endoscopy. The various, developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings, and to quote the intestine cleanliness. Assessment of diagnostic performance and reading time will be performed within a few months or up to five years, for each technological brick, individually and then combined, according to their stepwise development.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Any patient in whom a capsule endoscopy examination is performed as part of routine care. Exclusion Criteria: - Opposition to the use of images and videos from daily, routine care for research purposes.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centre d'Endoscopie Digestive Hôpital Saint-Antoine

Address:
City: Paris
Zip: 75012
Country: France

Status: Recruiting

Contact:
Last name: Xavier DRAY, MD PhD

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

Start date: February 10, 2023

Completion date: February 2028

Lead sponsor:
Agency: Assistance Publique - Hôpitaux de Paris
Agency class: Other

Source: Assistance Publique - Hôpitaux de Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06152289