Small Intestine DiseaseNAVIPILLNCT06462352
Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
A study testing Navicam SB capsule and Pillcam SB3 in people with Small Intestine Disease, run by Hospital Clinic of Barcelona at 16 sites in Spain.
Trial summary
Since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. However, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestine Disease
- What is being tested?
- Navicam SB capsule and Pillcam SB3
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 16 sitesSpain
- Study dates
- 27 May 2024to 31 Dec 2025
- 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
- Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.
Who cannot join
- Patients with known small bowel strictures detected by computed tomography (CT) or magnetic resonance imaging (MRI).
- Patients with a history of esophagogastric and small bowel surgery (excluding ileocecal resection).
- Patients with a clinical contraindication for small bowel capsule endoscopy.
- Hospitalized patients.
- Patients with pacemaker or Implantable Cardioverter Defibrillator (ICD).
- Patients scheduled for a MRI within 15 days after capsule endoscopy ingestion.
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- Pregnant or actively breastfeeding patients.
- Patients with swallowing disorders requiring endoscopic placement of the capsule.
- Simultaneous participation in another clinical trial using any investigational drug or device.
- Concurrent life-threatening pathology or condition.
- Inability to sign the informed consent form.
Trial locations and contacts
16 sites in 1 country.
Miguel Urpí Ferreruela, MD contact
16 sites in 1 country
Spain16 sites, 16 recruiting
- Not yet recruiting
Hospital General Universitario Dr Balmis
Alicante
Luis Compañy
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Begoña González Suárez, PhD
- Not yet recruiting
Hospital del Mar
Barcelona
Josep Dedeu Cuscó
- Not yet recruiting
Institut de Recerca Sant Pau (IR-Sant Pau)
Barcelona
Antonio Giordano, PhD
- Not yet recruiting
Hospital Universitario de Galdakao
Bilbao
Margarita Durán
- Not yet recruiting
Hospital General Universitario Virgen la Arrixaca
El Palmar
Juan Egea Valenzuela, PhD
- Not yet recruiting
Hospital General Universitario de Elche
Elche
Javier Sola Vera
- Not yet recruiting
Hospital Clínico San Carlos
Madrid
Francisco Sánchez Ceballos
- Not yet recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Oscar Nogales Ricón
Javier García Lledó
- Not yet recruiting
Hospital General Universitario Morales Meseguer
Murcia
Enrique Pérez Cuadrado, PhD
- Not yet recruiting
Hospital Universitario Son Espases
Palma de Mallorca
Carmen Garrido
- Not yet recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife
Mileidis San Juan Acosta, PhD
Pilar Borque Barrera
- Not yet recruiting
Hospital Universitario Virgen Macarena
Seville
Angel Caunedo
- Not yet recruiting
Hospital de Terrassa
Terrassa
Sara Galter
- Not yet recruiting
Hospital General Universitario de Valencia
Valencia
Marisol Luján Sanchis
- Not yet recruiting
Hospital Universitario i Politècnic La Fé
Valencia
Vicente Pons Beltrán, PhD
About this study
Official title: Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
Since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. However, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. The Navicam endoscopic capsule, leveraging artificial intelligence (AI) with ProScan™ for automated reading, promises to address these limitations by reducing reading times and enhancing diagnostic efficiency.
This study aims to assess the diagnostic concordance and to compare the efficiency of the AI-based Navicam capsule with the conventional Pillcam SB3 in the exploration of the small bowel.
Read the detailed description
This is a prospective, multicenter, randomized, observational study involving multiple hospitals across Spain. At each site, patients will ingest both the Pillcam SB3 and Navicam capsules in a randomized order. Reading times, transit times, and diagnostic yield will be compared between the two devices. A central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria.
The primary endpoint is the diagnostic concordance between Navicam's AI-driven ProScan™ system and the conventional reading of Pillcam SB3, measured by Cohen's kappa index.
The secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events.
The sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6.
This study aims to establish that the AI-based Navicam capsule is at least as effective as the conventional Pillcam SB3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.
- Conditions
- Small Intestine Disease
- Being tested
- Navicam SB capsule, Pillcam SB3
- Keywords
- capsule endoscopy, artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navicam SB capsuleDevice
Exploration of the small bowel by Navicam SB endoscopic capsule.
Pillcam SB3Device
Exploration of the small bowel by Pillcam SB3 endoscopic capsule.
| Study group | Role | What they receive |
|---|---|---|
| Navicam endoscopic capsule | Experimental | Navicam endoscopic capsule device for the study of small bowel pathology. Receives: Device: Navicam SB capsule |
| Pillcam endoscopic capsule | Active comparator | Pillcam SB3 endoscopic capsule device for the study of small bowel pathology. Receives: Device: Pillcam SB3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance correlation coefficient in small bowel exploration (per-patient analysis)
To assess the concordance (k agreement) between Navicam (with ProscanTM AI-system) and Pillcam endoscopic capsule device in detecting patients with at least one significant small bowel lesion.
Measured: From the start of recording up to 12 hours afterward
Secondary outcomes (4)
Correlation coefficient in lesion detection (per-lesion analysis)
To assess the correlation between Navicam (AI-tool Proscan) and Pillcam in detecting small bowel lesions.
Measured: From the start of recording up to 12 hours afterward
Reading time in minutes
To compare reading times of the small bowel between Navicam (Proscan) and Pillcam SB3.
Measured: From the start of recording up to 12 hours afterward
Transit times in minutes
To compare gastric, small bowel, and colonic transit times between Navicam and Pillcam SB3.
Measured: From the start of recording up to 12 hours afterward
Adverse events related to Navicam and/or Pillcam SB3
Describe any adverse events during small bowel exploration.
Measured: From the start of recording up to 24 hours afterward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start27 May 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestine DiseaseStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Responsible party
- Sponsor
- Investigators
- Begoña González Suárez, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462352
- Sponsor's protocol ID
- NAVIPILL
- Acronym
- NAVIPILL
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
- ClinicalTrials.gov ID
- NCT06462352
- Acronym / sponsor ID
- NAVIPILL / NAVIPILL
- Conditions
- Small Intestine Disease
- Keywords
- capsule endoscopy, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jun 2024 (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.
Since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. However, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. The Navicam endoscopic capsule, leveraging artificial intelligence (AI) with ProScan™ for automated reading, promises to address these limitations by reducing reading times and enhancing diagnostic efficiency.
This study aims to assess the diagnostic concordance and to compare the efficiency of the AI-based Navicam capsule with the conventional Pillcam SB3 in the exploration of the small bowel.
Detailed description
This is a prospective, multicenter, randomized, observational study involving multiple hospitals across Spain. At each site, patients will ingest both the Pillcam SB3 and Navicam capsules in a randomized order. Reading times, transit times, and diagnostic yield will be compared between the two devices. A central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria.
The primary endpoint is the diagnostic concordance between Navicam's AI-driven ProScan™ system and the conventional reading of Pillcam SB3, measured by Cohen's kappa index.
The secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events.
The sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6.
This study aims to establish that the AI-based Navicam capsule is at least as effective as the conventional Pillcam SB3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navicam endoscopic capsule | Experimental | Device: Navicam SB capsuleNavicam endoscopic capsule device for the study of small bowel pathology. |
| Pillcam endoscopic capsule | Active comparator | Device: Pillcam SB3Pillcam SB3 endoscopic capsule device for the study of small bowel pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.
Key exclusion criteria (11 listed)
- Patients with known small bowel strictures detected by computed tomography (CT) or magnetic resonance imaging (MRI).
- Patients with a history of esophagogastric and small bowel surgery (excluding ileocecal resection).
- Patients with a clinical contraindication for small bowel capsule endoscopy.
- Hospitalized patients.
- Patients with pacemaker or Implantable Cardioverter Defibrillator (ICD).
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 |
|---|---|---|
| Navicam SB capsuleExploration of the small bowel by Navicam SB endoscopic capsule. | Device | Navicam endoscopic capsule |
| Pillcam SB3Exploration of the small bowel by Pillcam SB3 endoscopic capsule. | Device | Pillcam endoscopic capsule |
Primary outcome
Concordance correlation coefficient in small bowel exploration (per-patient analysis)
Time frame: From the start of recording up to 12 hours afterward
To assess the concordance (k agreement) between Navicam (with ProscanTM AI-system) and Pillcam endoscopic capsule device in detecting patients with at least one significant small bowel lesion.
4 secondary outcomes
Correlation coefficient in lesion detection (per-lesion analysis)
Time frame: From the start of recording up to 12 hours afterward
Reading time in minutes
Time frame: From the start of recording up to 12 hours afterward
Transit times in minutes
Time frame: From the start of recording up to 12 hours afterward
Adverse events related to Navicam and/or Pillcam SB3
Time frame: From the start of recording up to 24 hours afterward
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Miguel Urpí Ferreruela, MD contact
Begoña González Suárez, PhD principal investigator
Hospital Clinic of Barcelona
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navicam SB capsule and Pillcam SB3 in people with Small Intestine Disease, run by Hospital Clinic of Barcelona at 16 sites in Spain.
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 11 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Begoña González Suárez, PhD (+34661334362, bgonzals@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance correlation coefficient in small bowel exploration (per-patient analysis) (time frame: From the start of recording up to 12 hours afterward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2024.