Artificial Intelligence-Guided Detection of Blood Vessels to Enhance Safety in Third-Space Endoscopic Procedures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAsian Institute of Gastroenterology, India

About this trial

This prospective study aims to evaluate the performance of a novel Artificial Intelligence (AI) clinical decision support tool during third space endoscopic procedures, such as Endoscopic Submucosal Dissection (ESD) and Peroral Endoscopic Myotomy (POEM).

While these procedures are effective for treating gastrointestinal neoplasms and motility disorders, they carry risks of intraprocedural bleeding and perforation if submucosal blood vessels are not correctly identified and coagulated. Building on previous retrospective validation, this study will assess whether a real-time artificial intelligence model can assist endoscopists in detecting and delineating blood vessels more accurately and faster during live human procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with Achalasia Cardia or neoplasms.

Disqualifiers

Patients with conditions deemed unsuitable for third space endoscopy procedures (e.g.: Candidiasis)

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI generated segmentation mask for sub-mucosal blood vessels

    Device

    Real time AI generated segmentation mask or delineation contours for sub-mucosal blood vessels visible on the endoscopy monitor.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: With Artificial IntelligenceActive comparator 1 intervention
Group B: Without Artificial IntelligenceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Vessel Detection Rate (VDR)

the proportion of vessels identified by the endoscopist

Time frame
3 months

Secondary outcomes

1

Vessel Detection Time (VDT)

The latency between a vessel appearing in the field of view and its identification.

Time frame
3 months

Other outcomes

Sponsors and contacts

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