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

February 19, 2024 updated by: Fondazione Poliambulanza Istituto Ospedaliero

Role of the Artificial Intelligence in Capsule Endoscopy for the Identification of Small Bowel Lesions in Patients With Small Intestinal Bleeding ArtIC Study: Artificial Intelligence Capsule Endoscopy Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

    2. 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.

    3. 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.

    4. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25124
        • Fondazione Poliambulanza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm study
Standard reading Group vs AI-assisted reading Group
Device: Capsule endoscopy

A consecutive series of patients recruited by 12 European centers based on the indication of OGIB will undergo capsule endoscopy examination.

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of AI-assisted video reading versus traditional video reading with conventional software.
Time Frame: through study completion, an average of 1 year
sensitivity, specificity, PPV, NPV calculated at per-patient analysis for P1 / P2 lesions, compared with the adjudication committee as gold standard in case of discrepancies.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
evaluation of Reading time of AI-assisted reading compared with conventional reading
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Role of AI-assisted reading in real life from a health economic perspective
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Accuracy of AI-assisted video reading versus traditional video reading with conventional software.
Time Frame: through study completion, an average of 1 year
Sensitivity, specificity, PPV, NPV, calculated at per lesion analysis for P1 / P2 lesions and for any lesion with the adjudication committee as gold standard in case of discrepancies .
through study completion, an average of 1 year
Accuracy of AI-assisted video reading versus traditional video reading with conventional software considering any lesions for a per-patient analysis with the adjudication committee as gold standard in case of discrepancies.
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Diagnostic yield of CE
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Number and type of findings / lesion detected
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Poliambulanza Istituto Ospedaliero

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospices Civils de Lyon
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hospital Clinic of Barcelona
Sheffield Teaching Hospitals NHS Foundation Trust
Saint Antoine University Hospital
Royal Free Hospital NHS Foundation Trust
Universitätsklinikum Hamburg-Eppendorf
Wuhan Union Hospital, China
Skane University Hospital
Szeged University
South Tyneside and Sunderland NHS Foundation Trust
Humanitas Hospital, Italy
Hospital Avicenne
Endo-Kapszula Magánorvosi Centrum
Northwick Park Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ArtiC STUDY-NP4350 v.05 140920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data and source code can be made available after the manuscript publication on reasonable request, which must include an appropriate protocol, analysis plan, and data exchange with institutional approvals in place before data transfer of any information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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