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Not yet recruiting NCT07633847

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.

— Observational Small Bowel Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video capsule endoscopy, Phase II = Data analysis by Independent Readers, Phase III = Data Analysis by Expert Readers.
Who it may be relevant to
Registry conditions: Small Bowel Bleeding. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Study Exploring the Difference of AI-Trained Software Compared to Conventional Interpretation Methods in Small Bowel Video Capsule Procedures

Overview

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.

Interventions

  • Device Video capsule endoscopy
    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.
  • Other Phase II = Data analysis by Independent Readers
    Independent video capsule readers to review and evaluate the videos from the capsule endoscopy procedure (Phase I), plus the ProScan videos.
  • Other Phase III = Data Analysis by Expert Readers
    An Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II).

Primary outcome measures

  • Subject-level sensitivity [Time frame: 24 months]
  • Subject-level specificity [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 3 centers
  • NYU Langone Health — New York
  • NYU Grossman School of Medicine — New York
  • Digestive Health Associates of Texas — Bedford

Identifiers

NCT: NCT07633847 · P05-CEP-0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗