CompletedNot Applicable

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

Italy137 participantsStarted 2021-02-16

Plain-language summary

Capsule Endoscopy (CE) is a safe, patient friendly and easy procedure performed for the evaluation of gastrointestinal tract unable to be explored via conventional endoscopy. The most common indication to perform SBCE is represented by Suspected Small Bowel Bleeding (SSBB). According to the widest meta-analysis available in literature, SBCE shows a diagnostic yield in SSBB of about 60%, and angiodysplasias are the most relevant findings, accounting for 50% of patients undergoing SBCE for SSBB. Accordingly, it represents the first line examination in SSBB investigation for determining the source of bleeding, if primary endoscopy results negative. Despite its high clinical feasibility, the evaluation of CE-video-captures is one of the main drawbacks since it is time consuming and requests the reader to concentrate to not miss any lesion. In order to reduce reading time, several software have been developed with the aim to cut similar images and select relevant images. For example, automated fast reading software have demonstrated to significantly reduce reading time without impacting the miss rate in pathological conditions affecting diffusely the mucosa (as IBD lesions do). Not the same assumption can be taken for isolated lesions since several studies reported an unacceptable miss rate for such a detection modality. New advancements such as artificial intelligence made their appearance in recent years. Deep convolutional neural networks (CNNs) have demonstrated to recognize specific images among a large variety up to exceed human performance in visual tasks. A Deep Learning model has been recently validated in the field of Small Bowel CE by Ding et al. According to their data collected on 5000 patients, the CNN-based auxiliary model identify abnormalities with 99.88% sensitivity in the per patient analysis and 99.90% sensitivity in the per-lesion analysis. With this perspective, it is believable that AI applied to SBCE can significantly shorten the reading time and support physicians to detect available lesions without losing significant lesions, further improving the diagnostic yield of the procedure.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accuracy of AI-assisted video reading versus traditional video reading with conventional software.

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT04821349

SponsorFondazione Poliambulanza Istituto Ospedaliero

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-05

View on ClinicalTrials.gov More Iron Deficiency Anemia trials