Iron Deficiency AnemiaArtICNCT04821349
Role of AI in CE for the Identification of SB Lesions in Patients With Small Intestinal Bleeding.
A study testing Capsule endoscopy in people with Iron Deficiency Anemia and Obscure Gastrointestinal Bleeding, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia, Obscure Gastrointestinal Bleeding
- What is being tested?
- Capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteItaly
- Study dates
- 16 Feb 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication of OGIB:1)after negative upper and lower endoscopy; 2)France: after negative pregnancy test; 3)Hb cut-off male: <13, female: <12
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- Being tested
- Capsule endoscopy
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule endoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | Standard reading Group vs AI-assisted reading Group Receives: Device: Capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AI-assisted video reading versus traditional video reading with conventional software.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
evaluation of Reading time of AI-assisted reading compared with conventional reading
Measured: through study completion, an average of 1 year
Role of AI-assisted reading in real life from a health economic perspective
Measured: through study completion, an average of 1 year
Accuracy of AI-assisted video reading versus traditional video reading with conventional software.
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 .
Measured: 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.
Measured: through study completion, an average of 1 year
Diagnostic yield of CE
Measured: through study completion, an average of 1 year
Number and type of findings / lesion detected
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start16 Feb 2021
- Primary completion5 May 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Skane University Hospital, Hospital Clinic of Barcelona, Universitätsklinikum Hamburg-Eppendorf, Sheffield Teaching Hospitals NHS Foundation Trust, Endo-Kapszula Magánorvosi Centrum, Szeged University, Saint Antoine University Hospital, Hospital Avicenne, South Tyneside and Sunderland NHS Foundation Trust, Northwick Park Hospital, Hospices Civils de Lyon, Royal Free Hospital NHS Foundation Trust, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821349
- Sponsor's protocol ID
- ArtiC STUDY-NP4350 v.05 140920
- Acronym
- ArtIC
- Status last verified
- Nov 2022
- First submitted
- 12 Mar 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Spada C, Piccirelli S, Hassan C, Ferrari C, Toth E, Gonzalez-Suarez B, Keuchel M, McAlindon M, Finta A, Rosztoczy A, Dray X, Salvi D, Riccioni ME, Benamouzig R, Chattree A, Humphries A, Saurin JC, Despott EJ, Murino A, Johansson GW, Giordano A, Baltes P, Sidhu R, Szalai M, Helle K, Nemeth A, Nowak T, Lin R, Costamagna G. AI-assisted capsule endoscopy reading in suspected small bowel bleeding: a multicentre prospective study. Lancet Digit Health. 2024 May;6(5):e345-e353. doi: 10.1016/S2589-7500(24)00048-7.
PubMed 38670743
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04821349
- Acronym / sponsor ID
- ArtIC / ArtiC STUDY-NP4350 v.05 140920
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Skane University Hospital, Hospital Clinic of Barcelona, Universitätsklinikum Hamburg-Eppendorf, Sheffield Teaching Hospitals NHS Foundation Trust, Endo-Kapszula Magánorvosi Centrum, Szeged University, Saint Antoine University Hospital, Hospital Avicenne, South Tyneside and Sunderland NHS Foundation Trust, Northwick Park Hospital, Hospices Civils de Lyon, Royal Free Hospital NHS Foundation Trust, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Device: Capsule endoscopyStandard reading Group vs AI-assisted reading Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication of OGIB:1)after negative upper and lower endoscopy; 2)France: after negative pregnancy test; 3)Hb cut-off male: <13, female: <12
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsule endoscopyA 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. | Device | Single arm study |
Primary outcome
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.
6 secondary outcomes
evaluation of Reading time of AI-assisted reading compared with conventional reading
Time frame: 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
Accuracy of AI-assisted video reading versus traditional video reading with conventional software.
Time frame: 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
Diagnostic yield of CE
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 38670743Spada C, Piccirelli S, Hassan C, Ferrari C, Toth E, Gonzalez-Suarez B, Keuchel M, McAlindon M, Finta A, Rosztoczy A, Dray X, Salvi D, Riccioni ME, Benamouzig R, Chattree A, Humphries A, Saurin JC, Despott EJ, Murino A, Johansson GW, Giordano A, Baltes P, Sidhu R, Szalai M, Helle K, Nemeth A, Nowak T, Lin R, Costamagna G. AI-assisted capsule endoscopy reading in suspected small bowel bleeding: a multicentre prospective study. Lancet Digit Health. 2024 May;6(5):e345-e353. doi: 10.1016/S2589-7500(24)00048-7.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule endoscopy in people with Iron Deficiency Anemia and Obscure Gastrointestinal Bleeding, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of AI-assisted video reading versus traditional video reading with conventional software. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.