Skip to content

Development of New Diagnostic Tools in Capsule Endoscopy

Development of New Diagnostic Tools in Capsule Endoscopy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06152289
Acronym
NOCE
Enrollment
10000
Registered
2023-11-30
Start date
2023-02-10
Completion date
2028-02-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Disease, Celiac Disease, Chronic Diarrhea, Crohn Disease, Tumor

Keywords

Small bowel, Capsule endoscopy, Artificial intelligence

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.

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Develop an artificial intelligence solution to help with diagnosis in VCEThrough study completion, 5 yearsSensitivity 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)

Secondary

MeasureTime frameDescription
Evaluation of the diagnostic performance of the A.I. solution in terms of detectionThrough study completion, 5 yearsOther diagnostic performance (specificity, positive and negative predictive values, accuracy) 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)
Evaluation of the diagnostic performance of the A.I. solution in terms of characterisationThrough study completion, 5 yearsTime needed for detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)
Evaluation of the diagnostic performance of the A.I. solution in terms of recognition of anatomical landmarksThrough study completion, 5 yearsDiagnostic performances in positioning anatomical landmarks (1st gastric, small bowl and colonic images) as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)
Evaluation of the diagnostic performance of the A.I. solution in terms of quality of preparation of the various segments of the digestive tractThrough study completion, 5 yearsDiagnostic performances in quoting small bowel and colonic quality of preparation, as compared toed centrally and consensually quoted by a panel of 3 expert readers

Countries

France

Contacts

CONTACTXavier DRAY, MD PhD
Xavier.dray@aphp.fr+33 (0) 49 28 21 60
CONTACTRomain LEENHARDT, MD
romain.leenhardt@aphp.fr+33 (0) 1 49 28 21 61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026