Small Bowel BleedingPROCEEDNCT07633847
A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.
An observational study of Small Bowel Bleeding, run by AnX Robotica Corp. at 3 sites in United States.
Trial summary
NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Small Bowel Bleeding
- What is being tested?
- Video capsule endoscopy, Phase II = Data analysis by Independent Readers and Phase III = Data Analysis by Expert Readers
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 92 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jun 2026to 15 Sep 2028
- How long will I take part?
- 14 Days
- Phase
- Observational
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 22 years old or older
Who may be able to join
- Patients of all genders, races, ethnicities and geographical backgrounds, from 22 years of age or older.
- Patient agrees to sign informed consent and follow all study procedures.
Who cannot join
- In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- In patients with cardiac pacemakers or other implantable electronic medical devices (MR unsafe devices only).
- In patients with dysphagia with high risk of aspiration.
- In pregnant women.
- GI motility issues (gastroparesis)
- GI dysmotility
Show all 11Show fewer
- Chronic opioid usage
- Requires endoscopic placement
- In patients with endoscopic biopsies within one week of scheduled capsule ingestion
- No NSAID use within 14 days of scheduled capsule ingestion
- No GLP-1 drugs within 7 days of scheduled capsule ingestion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Digestive Health Associates of Texas
Bedford, Texas, 76002
Jay Yepuri, MD, 817-267-8470 ext. 117, jay.yepuri@dhat.com
NYU Langone Health
New York, New York, 10016
Melissa Latorre Debordeaux, MD MS, 646-501-9795, Melissa.Debordeaux@nyulangone.org
NYU Grossman School of Medicine
New York, New York, 10022
David Poppers, MD PhD, 646-754-2000, david.poppers@nyulangone.org
About this study
Official title: Prospective Study Exploring the Difference of AI-Trained Software Compared to Conventional Interpretation Methods in Small Bowel Video Capsule Procedures
NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.
Read the detailed description
The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. The tool is not intended to replace clinical decision making.
- Conditions
- Small Bowel Bleeding
- Being tested
- Video capsule endoscopy, Phase II = Data analysis by Independent Readers, Phase III = Data Analysis by Expert Readers
- Keywords
- artificial intelligent, assisted reading tool, capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video capsule endoscopyDevice
Phase I = Data Collection. The video from the capsule endoscopy procedure will be reviewed and reported by the treating physician. Once the capsule has passed and any adverse events have been collected, there will be no additional patient follow-up.
Phase II = Data analysis by Independent ReadersOther
Independent video capsule readers to review and evaluate the videos from the capsule endoscopy procedure (Phase I), plus the ProScan videos.
Phase III = Data Analysis by Expert ReadersOther
An Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II).
| Study group | Role | What they receive |
|---|---|---|
| NaviCam VCE (video capsule endoscopy) | Adults 22 years of age or older who received a NaviCam capsule endoscopy procedure Receives: Device: Video capsule endoscopy; Other: Phase II = Data analysis by Independent Readers; Other: Phase III = Data Analysis by Expert Readers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-level sensitivity
Subject-level sensitivity will be evaluated for superiority of ProScan assistance versus unassisted assessments in the identification of patients with one or more true findings.
Measured: 24 months
Subject-level specificity
Subject-level sensitivity will be evaluated for non-inferiority of superiority of ProScan assistance versus unassisted assessments in the identification of patients with no ground truth findings.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel BleedingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- AnX Robotica Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shabana Pasha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633847
- Sponsor's protocol ID
- P05-CEP-0002
- Acronym
- PROCEED
- Status last verified
- Jun 2026
- First submitted
- 24 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Exploring the Difference of AI-Trained Software Compared to Conventional Interpretation Methods in Small Bowel Video Capsule Procedures
- ClinicalTrials.gov ID
- NCT07633847
- Acronym / sponsor ID
- PROCEED / P05-CEP-0002
- Conditions
- Small Bowel Bleeding
- Keywords
- artificial intelligent, assisted reading tool, capsule endoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- AnX Robotica Corp.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 8 Jun 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.
NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.
Detailed description
The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. The tool is not intended to replace clinical decision making.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NaviCam VCE (video capsule endoscopy) | – | Device: Video capsule endoscopy, Other: Phase II = Data analysis by Independent Readers, Other: Phase III = Data Analysis by Expert ReadersAdults 22 years of age or older who received a NaviCam capsule endoscopy procedure |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 22 years old or older
Key inclusion criteria (2 listed)
- Patients of all genders, races, ethnicities and geographical backgrounds, from 22 years of age or older.
- Patient agrees to sign informed consent and follow all study procedures.
Key exclusion criteria (11 listed)
- In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- In patients with cardiac pacemakers or other implantable electronic medical devices (MR unsafe devices only).
- In patients with dysphagia with high risk of aspiration.
- In pregnant women.
- GI motility issues (gastroparesis)
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 |
|---|---|---|
| Video capsule endoscopyPhase I = Data Collection. The video from the capsule endoscopy procedure will be reviewed and reported by the treating physician. Once the capsule has passed and any adverse events have been collected, there will be no additional patient follow-up. | Device | NaviCam VCE (video capsule endoscopy) |
| Phase II = Data analysis by Independent ReadersIndependent video capsule readers to review and evaluate the videos from the capsule endoscopy procedure (Phase I), plus the ProScan videos. | Other | NaviCam VCE (video capsule endoscopy) |
| Phase III = Data Analysis by Expert ReadersAn Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II). | Other | NaviCam VCE (video capsule endoscopy) |
Primary outcome
Subject-level sensitivity
Time frame: 24 months
Subject-level sensitivity will be evaluated for superiority of ProScan assistance versus unassisted assessments in the identification of patients with one or more true findings.
Subject-level specificity
Time frame: 24 months
Subject-level sensitivity will be evaluated for non-inferiority of superiority of ProScan assistance versus unassisted assessments in the identification of patients with no ground truth findings.
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 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Small Bowel Bleeding
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Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
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Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding
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RecruitingObservational study
Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon
Obscure Gastrointestinal Bleeding, Anemia, Iron Deficiency
Enrolling by invitation
Urgent Panendoscopy in Patients Presenting With Hematochezia
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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.
Shabana Pasha, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Bleeding, run by AnX Robotica Corp. at 3 sites in United States.
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 2 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 Tim Thomas, RAC (770-480-2911, tim.thomas@anxrobotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject-level sensitivity (time frame: 24 months). The study lists 2 primary outcomes in all. 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 8 Jun 2026.