Stomach CancerNEOTOGASNCT07323186
Evaluation of the NEOmom® Gastric Video Capsule for Gastric Cancer Screening
A study of Stomach Cancer and Diagnosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Gastric cancer remains a major public health concern, with approximately 6,600 new cases diagnosed each year in France. Despite therapeutic progress, its overall prognosis is still poor: the 5-year survival rate across all stages remains below 30%. This survival is closely linked to the stage at diagnosis. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Stomach Cancer, Diagnosis, Endoscopy of Stomach (Procedure)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2025to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient,
- Aged between 50 and 74 inclusive with a life expectancy of at least 10 years,
- Undergoing screening or surveillance colonoscopy (for colorectal cancer or polyps)
- Patient who has received verbal and written information as well as a patient booklet on the VCE-CM examination and has given their written informed consent.
- Patient affiliated with a social security scheme
- Effective contraception throughout the study for women of childbearing age
Who cannot join
- Patients who have had or currently have the following (items from the TOGAS pilot study/specific to endoscope use) will not be included in the study:
- An EOGD in a high-volume endoscopy centre within the last 3 years
- Known gastric cancer
- Known genetic cancer syndromes
- Previous gastrectomy or bariatric gastric surgery
- Known gastric precancerous condition (gastric atrophy, intestinal metaplasia, dysplasia)
Show all 21Show fewer
- Acute gastrointestinal haemorrhage in the last 4 weeks
- A coagulation disorder or medication that prevents biopsy sampling
- A risk associated with sedation or anaesthesia
- Severe heart disease
- An inability to actively consent to participation in the study, and patients under guardianship or legal protection.
- Pregnant or breastfeeding patients will not be included.
- Patients with the following conditions (specific to VCE-CM examination) will not be included in the study:
- Swallowing disorders or known gastroparesis
- A history of digestive surgery
- Clinical or radiological signs suggestive of narrowing of the digestive tract
- An occlusive or sub-occlusive condition, a known or suspected history of stenosis or digestive fistula
- Left heart failure with orthopnoea
- Overweight (> 135 kg)
- Reduced mobility (i.e. unable to transfer or move themselves)
- Persons with pacemakers, defibrillators or metallic foreign bodies (with the exception of dental implants) will not be included in order to avoid interference with the robot.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Selma El Andaloussi, Project Manager contact
France1 site
Nantes University Hospital
Nantes, 44000
Emmanuel CORON, PU-PH, France +33 02 40 08 31 52, emmanuel.coron@chu-nantes.fr
About this study
Gastric cancer remains a major public health concern, with approximately 6,600 new cases diagnosed each year in France. Despite therapeutic progress, its overall prognosis is still poor: the 5-year survival rate across all stages remains below 30%. This survival is closely linked to the stage at diagnosis. Early-stage gastric cancer has an excellent prognosis, with survival rates above 90%, while advanced-stage disease shows survival below 10%. This dramatic contrast underscores the critical need to develop and implement approaches that enable earlier and more reliable diagnosis. Early detection is therefore one of the most powerful strategies to reduce mortality from this severe and often silent disease.
Within this context, the overall ambition of the NEOTOGAS project is to contribute to lowering gastric-cancer mortality by improving the ability to diagnose the disease at an early, more treatable stage. The project positions itself within the broader field of prevention, targeting one of the leading and most challenging public health issues. Gastric cancer is often a potentially fatal condition that typically develops over many years, most commonly as a consequence of chronic infection with Helicobacter pylori (H. pylori). Identifying precancerous gastric lesions before the appearance of invasive cancer thus represents a strategic priority for the healthcare system.
Read more
Our central hypothesis is that a non-invasive, robot-assisted endoscopic approach using a magnetic-guided capsule-the NEOMOM system-will prove effective for detecting precancerous gastric lesions. If validated, this technology could form the foundation of an organized, large-scale screening program. Such a screening strategy would represent a major innovation, particularly in populations at higher risk due to H. pylori infection or other predispositions. The ability to offer a less invasive, more accessible examination could significantly increase screening adherence and facilitate earlier diagnosis.
The NEOTOGAS study is based on an innovative combination of technologies: a magnetic-guided videocapsule steered inside the stomach using the NEOMOM robot, supported by artificial intelligence to assist image acquisition and interpretation. The study aims to assess the level of concordance between lesion detection through the current gold-standard procedure (conventional endoscopy) and this new capsule-based examination. Beyond diagnostic performance, the project also integrates several essential dimensions for future implementation: patient acceptability of the procedure, overall cost, duration of the examination, and the potential clinical and organizational benefits of this alternative approach.
A key component of the project is the creation of high-quality image banks. These will support the development of advanced AI models capable of enhancing lesion detection and ensuring the completeness of the stomach examination. Such resources will be instrumental in evaluating whether magnetic-guided capsule endoscopy could realistically be integrated into structured gastric cancer screening pathways in the future. The project therefore aims not only to evaluate a device, but also to explore its broader screening potential and its capacity to transform clinical practice.
The primary objective of the NEOTOGAS study is to rigorously assess the performance of this innovative medical device, which combines magnetic navigation with AI-assisted image interpretation, in detecting gastric lesions. The AI module plays a dual role: ensuring that the entire stomach is adequately explored and helping highlight images of interest for clinicians during analysis. By improving both completeness and accuracy, the technology could represent a significant advancement over existing non-invasive diagnostic tools.
To achieve these goals, the study plans to include a total of 100 patients over a 6-month period. This sample size will allow a robust comparison of diagnostic concordance while providing sufficient data to evaluate feasibility, patient experience, and operational parameters. The findings of NEOTOGAS will determine whether magnetic-guided capsule endoscopy can be considered a relevant and effective method for future organized gastric cancer screening programs.
- Conditions
- Stomach Cancer, Diagnosis, Endoscopy of Stomach (Procedure)
- Being tested
- Magnetically controlled video capsule endoscopy (MC-VCE)
- Keywords
- stomach cancer
- Medical subject headings
- Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetically controlled video capsule endoscopy (MC-VCE)Device
-Intervention 1 description: Ingestion of the NEOMOM® magnetically controlled video capsule, guided by an external magnetic field and coupled with an artificial intelligence module to ensure completeness of gastric examination and assist in lesion detection.
-Intervention 2 Description: Conventional oesophagogastroduodenal endoscopy performed according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| magnetically controlled video capsule endoscope + Standard EGD | Experimental | Participants undergo both magnetically controlled video capsule endoscopy and standard oesophagogastroduodenal endoscopy during the same visit, allowing intra-patient comparison of lesion detection. Receives: Device: Magnetically controlled video capsule endoscopy (MC-VCE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion-level concordance in gastric lesion detection between magnetic-controlled video capsule endoscopy and standard oesophagogastroduodenal endoscopy
Lesion-level concordance between magnetic-controlled video capsule endoscopy (MC-VCE) and standard oesophagogastroduodenal endoscopy (EGD) for the detection of gastric lesions.
Concordance will be expressed as agreement between the two modalities based on paired lesion detection (presence/absence), using expert review of recorded examinations.
In case of discordant findings, an independent adjudication committee composed of two expert clinicians blinded to the initial readings will determine the final classification.
Measured: Periprocedural (during the study visit) through image review within 72 hours after the examination (up to Day 8 in case of delayed capsule excretion)
Secondary outcomes (6)
Completeness of gastric examination assessed by magnetic-controlled video capsule endoscopy compared with standard oesophagogastroduodenal endoscopy
Proportion of complete gastric examinations achieved with magnetic-controlled video capsule endoscopy, as assessed by expert clinicians and compared with standard oesophagogastroduodenal endoscopy.
Completeness is defined as visualization of all predefined gastric anatomical regions.
Measured: Periprocedural (during the study visit) through image review within 72 hours after the examination
Lesion-by-lesion diagnostic performance of magnetic-controlled video capsule endoscopy compared with standard oesophagogastroduodenal endoscopy
Lesion-by-lesion diagnostic performance of magnetic-controlled video capsule endoscopy compared with standard oesophagogastroduodenal endoscopy, expressed as sensitivity, specificity, positive predictive value, and negative predictive value, using EGD as the reference standard.
Measured: Periprocedural (during the study visit) through image review within 72 hours after the examination
Diagnostic performance of magnetic-controlled video capsule endoscopy for major gastric lesions compared with standard oesophagogastroduodenal endoscopy
Diagnostic performance of magnetic-controlled video capsule endoscopy for predefined major gastric lesions (gastric tumors, gastric ulcers, gastric cancer), expressed as sensitivity, specificity, positive predictive value, and negative predictive value, using standard oesophagogastroduodenal endoscopy as the reference standard.
Measured: Periprocedural (during the study visit) through image review within 72 hours after the examination
Concordance between expert reading and artificial intelligence-assisted reading of magnetic-controlled video capsule endoscopy images
Lesion detection concordance between conventional expert clinician reading and automated reading using the artificial intelligence module (Vue Smart V7 software) applied to magnetic-controlled video capsule endoscopy images.
Diagnostic performance will be expressed as sensitivity, specificity, positive predictive value, and negative predictive value of AI-assisted reading compared with expert clinician interpretation
Measured: Image review within 72 hours after the examination
Diagnostic concordance between non-invasive blood tests combined with magnetic-controlled video capsule endoscopy and biopsies combined with standard oesophagogastroduodenal endoscopy
Diagnostic concordance between magnetic-controlled video capsule endoscopy combined with predefined non-invasive blood tests and standard oesophagogastroduodenal endoscopy combined with gastric biopsies, based on final diagnostic classification
Measured: Periprocedural (during the study visit) through availability of histological results (up to Day 8)
Patient-reported acceptability score of magnetic-controlled video capsule endoscopy
Patient-reported acceptability of magnetic-controlled video capsule endoscopy measured using a structured questionnaire with an ordinal scale.
Scores range from 0 to 10, with higher scores indicating better acceptability.
Measured: Within 24 hours after completion of the magnetic-controlled video capsule endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323186
- Sponsor's protocol ID
- RC25_0258
- Acronym
- NEOTOGAS
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 7 Jan 2026
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the NEOmom® Gastric Video Capsule for Gastric Cancer Screening
- ClinicalTrials.gov ID
- NCT07323186
- Acronym / sponsor ID
- NEOTOGAS / RC25_0258
- Conditions
- Stomach Cancer, Diagnosis, Endoscopy of Stomach (Procedure)
- Keywords
- stomach cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 7 Jan 2026 (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.
Gastric cancer remains a major public health concern, with approximately 6,600 new cases diagnosed each year in France. Despite therapeutic progress, its overall prognosis is still poor: the 5-year survival rate across all stages remains below 30%. This survival is closely linked to the stage at diagnosis. Early-stage gastric cancer has an excellent prognosis, with survival rates above 90%, while advanced-stage disease shows survival below 10%. This dramatic contrast underscores the critical need to develop and implement approaches that enable earlier and more reliable diagnosis. Early detection is therefore one of the most powerful strategies to reduce mortality from this severe and often silent disease.
Within this context, the overall ambition of the NEOTOGAS project is to contribute to lowering gastric-cancer mortality by improving the ability to diagnose the disease at an early, more treatable stage. The project positions itself within the broader field of prevention, targeting one of the leading and most challenging public health issues. Gastric cancer is often a potentially fatal condition that typically develops over many years, most commonly as a consequence of chronic infection with Helicobacter pylori (H. pylori). Identifying precancerous gastric lesions before the appearance of invasive cancer thus represents a strategic priority for the healthcare system.
Our central hypothesis is that a non-invasive, robot-assisted endoscopic approach using a magnetic-guided capsule-the NEOMOM system-will prove effective for detecting precancerous gastric lesions. If validated, this technology could form the foundation of an organized, large-scale screening program. Such a screening strategy would represent a major innovation, particularly in populations at higher risk due to H. pylori infection or other predispositions. The ability to offer a less invasive, more accessible examination could significantly increase screening adherence and facilitate earlier diagnosis.
The NEOTOGAS study is based on an innovative combination of technologies: a magnetic-guided videocapsule steered inside the stomach using the NEOMOM robot, supported by artificial intelligence to assist image acquisition and interpretation. The study aims to assess the level of concordance between lesion detection through the current gold-standard procedure (conventional endoscopy) and this new capsule-based examination. Beyond diagnostic performance, the project also integrates several essential dimensions for future implementation: patient acceptability of the procedure, overall cost, duration of the examination, and the potential clinical and organizational benefits of this alternative approach.
A key component of the project is the creation of high-quality image banks. These will support the development of advanced AI models capable of enhancing lesion detection and ensuring the completeness of the stomach examination. Such resources will be instrumental in evaluating whether magnetic-guided capsule endoscopy could realistically be integrated into structured gastric cancer screening pathways in the future. The project therefore aims not only to evaluate a device, but also to explore its broader screening potential and its capacity to transform clinical practice.
The primary objective of the NEOTOGAS study is to rigorously assess the performance of this innovative medical device, which combines magnetic navigation with AI-assisted image interpretation, in detecting gastric lesions. The AI module plays a dual role: ensuring that the entire stomach is adequately explored and helping highlight images of interest for clinicians during analysis. By improving both completeness and accuracy, the technology could represent a significant advancement over existing non-invasive diagnostic tools.
To achieve these goals, the study plans to include a total of 100 patients over a 6-month period. This sample size will allow a robust comparison of diagnostic concordance while providing sufficient data to evaluate feasibility, patient experience, and operational parameters. The findings of NEOTOGAS will determine whether magnetic-guided capsule endoscopy can be considered a relevant and effective method for future organized gastric cancer screening programs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnetically controlled video capsule endoscope + Standard EGD | Experimental | Device: Magnetically controlled video capsule endoscopy (MC-VCE)Participants undergo both magnetically controlled video capsule endoscopy and standard oesophagogastroduodenal endoscopy during the same visit, allowing intra-patient comparison of lesion detection. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient,
- Aged between 50 and 74 inclusive with a life expectancy of at least 10 years,
- Undergoing screening or surveillance colonoscopy (for colorectal cancer or polyps)
- Patient who has received verbal and written information as well as a patient booklet on the VCE-CM examination and has given their written informed consent.
- Patient affiliated with a social security scheme
Key exclusion criteria (21 listed)
- Patients who have had or currently have the following (items from the TOGAS pilot study/specific to endoscope use) will not be included in the study:
- An EOGD in a high-volume endoscopy centre within the last 3 years
- Known gastric cancer
- Known genetic cancer syndromes
- Previous gastrectomy or bariatric gastric surgery
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 |
|---|---|---|
| Magnetically controlled video capsule endoscopy (MC-VCE)-Intervention 1 description: Ingestion of the NEOMOM® magnetically controlled video capsule, guided by an external magnetic field and coupled with an artificial intelligence module to ensure completeness of gastric examination and assist in lesion detection. -Intervention 2 Description: Conventional oesophagogastroduodenal endoscopy performed according to standard clinical practice. | Device | magnetically controlled video capsule endoscope + Standard EGD |
Primary outcome
Lesion-level concordance in gastric lesion detection between magnetic-controlled video capsule endoscopy and standard oesophagogastroduodenal endoscopy
Time frame: Periprocedural (during the study visit) through image review within 72 hours after the examination (up to Day 8 in case of delayed capsule excretion)
Lesion-level concordance between magnetic-controlled video capsule endoscopy (MC-VCE) and standard oesophagogastroduodenal endoscopy (EGD) for the detection of gastric lesions. Concordance will be expressed as agreement between the two modalities based on paired lesion detection (presence/absence), using expert review of recorded examinations. In case of discordant findings, an independent adjudication committee composed of two expert clinicians blinded to the initial readings will determine the final classification.
6 secondary outcomes
Completeness of gastric examination assessed by magnetic-controlled video capsule endoscopy compared with standard oesophagogastroduodenal endoscopy
Time frame: Periprocedural (during the study visit) through image review within 72 hours after the examination
Lesion-by-lesion diagnostic performance of magnetic-controlled video capsule endoscopy compared with standard oesophagogastroduodenal endoscopy
Time frame: Periprocedural (during the study visit) through image review within 72 hours after the examination
Diagnostic performance of magnetic-controlled video capsule endoscopy for major gastric lesions compared with standard oesophagogastroduodenal endoscopy
Time frame: Periprocedural (during the study visit) through image review within 72 hours after the examination
Concordance between expert reading and artificial intelligence-assisted reading of magnetic-controlled video capsule endoscopy images
Time frame: Image review within 72 hours after the examination
Diagnostic concordance between non-invasive blood tests combined with magnetic-controlled video capsule endoscopy and biopsies combined with standard oesophagogastroduodenal endoscopy
Time frame: Periprocedural (during the study visit) through availability of histological results (up to Day 8)
Patient-reported acceptability score of magnetic-controlled video capsule endoscopy
Time frame: Within 24 hours after completion of the magnetic-controlled video capsule endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- 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.
Selma El Andaloussi, Project Manager contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stomach Cancer and Diagnosis, run by Nantes University Hospital at 1 site in France.
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 6 inclusion and 21 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selma El Andaloussi, Project Manager (FRANCE +33 2 53 48 28 35, selma.elandaloussi@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion-level concordance in gastric lesion detection between magnetic-controlled video capsule endoscopy and standard oesophagogastroduodenal endoscopy (time frame: Periprocedural (during the study visit) through image review within 72 hours after the examination (up to Day 8 in case of delayed capsule excretion)). 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 7 Jan 2026.