Role of AI in CE for the Identification of SB Lesions in Patients With Small Intestinal Bleeding.

This is a multicenter, multinational, blinded prospective trial, involving a consecutive series of patients recruited by 12 European centers based on the indication of OGIB:

• after negative upper and lower endoscopy
• France: after negative pregnancy test
• Hb cut-off male: <13, female: <12 Capsule endoscopy will be performed in each site according to local rules and requirements, and the study protocol will concern only the post-procedure analysis on reading modalities for each patient, as specified below.1. Regimen of preparation AI depends on the possibility of the software to "see" images. An inadequate cleansing level precludes a proper visualization and the impact of technology. In order to have homogenous results, a standard regimen of preparation is advisable. The regimen includes a split dose of PEG-based solution (PlenVu, Moviprep) as recommended by ESGE guideline - technical report. Dose 1 will be administered at 7 pm of the day before and dose 2 in the morning of the procedure in order to be completed at least 1 hour before capsule ingestion. On the day before patients can have breakfast and a light meal. After lunch they should be fasting. Two and 4 hours after capsule ingestion patient are allowed to drink clear liquids and a light meal, respectively.

• Standard reading Each center will review the images collected according to the "normal reading" as recommended by ESGE guidelines. To compare reading time correctly, readers must read the video without including annotation of images. All lesions should be considered independently of their relevance. Findings are not marked on every image if they appear repeatedly on every consecutive image, but if they appear repeatedly with normal images in between. Annotations should be done after the reading, each lesion shall be labelled if it belongs to P1/2 category according to the Saurin Classification. Definition of P1, P2: red spots on the intestinal mucosa or small or isolated erosions or angioectasia, ulcers, tumors or varices or any other bleeding abnormality.

• AI-assisted reading Each center will receive from another center anonymized patient videos that have been uploaded on an encrypted USB key. Indeed, expert gastroenterologists from each center will proceed with AI-assisted video reading without knowing which center the video comes from nor the results of the normal reading. Reading conditions are the same as for standard reading.

• Consensus reading Results from both normal and AI-assisted reading will be compared. In the case of significant disagreement between the results from conventional capsule endoscopy reading and AI-assisted reading (e.g. missed lesions), a consensus review for each center will be done. Any lesion shall be considered.

Inclusion criteria

indication of OGIB:1)after negative upper and lower endoscopy; 2)France: after negative pregnancy test; 3)Hb cut-off male: <13, female: <12

Exclusion criteria

• Age < 18 years old
• Known or suspected intestinal obstruction
• Non-steroidal anti-inflammatory drugs (twice weekly or more) during the 4 weeks preceding enrollment
• Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
• Patient with known gastrointestinal motility disorders
• Subjects with known or suspected delayed gastric emptying
• Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions
• Patient has any allergy or other known contraindication or intolerance to the medications used in the study
• Patient has any condition, which precludes compliance with study and/or device instructions
• Patient with any contraindication to take the bowel preparation product
• Women who are either pregnant or nursing at the time of screening, or are of child- bearing potential and do not practice medically acceptable methods of contraception
• Concurrent participation in another clinical trial using any investigational drug or device
• Patient suffers from a life-threatening condition
• Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters
• Patients with pace-maker or implantable cardioverter
• Patient did not sign informed consent
• Endoscopic placement of the capsule