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NCT Number: NCT07399652

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

Location status: Recruiting

Location contact

Abhishek Tyagi, M.S.

CONTACT

[email protected]

919989154556

Abhishek Tyagi, M.S.

PRINCIPAL_INVESTIGATOR

About this study

Background and Rationale

Third-space endoscopy procedures are technically demanding. The primary challenge lies in the inadvertent transection of submucosal vessels, which leads to bleeding that obscures the surgical field and increases the risk of perforation. Currently, vessel identification is entirely operator-dependent.

Our team has developed a deep-learning based artificial intelligence model trained on 250,000 annotated images from 150 POEM procedures. This model is optimized for minimal latency, allowing for real-time visual overlays (delineation) of blood vessels on the endoscopic monitor.

Study Objectives The primary objective is to evaluate the Vessel Detection Rate (VDR)-the proportion of vessels identified by the endoscopist when assisted by the AI compared to standard practice.

The study will also investigate:

Vessel Detection Time (VDT): The latency between a vessel appearing in the field of view and its identification.

Study Design & Workflow:

In this prospective study, the AI system will be integrated into the Olympus EVIS X1 series endoscopy stack. As the endoscopist navigates the submucosal space, the AI will provide real-time visual segmentation masks highlighting vessels. The performance will be recorded and compared against a post-procedure review by independent experts to calculate sensitivity and detection speed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with Achalasia Cardia or neoplasms.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Vessel Detection Rate (VDR)

    Time frame: 3 months

    the proportion of vessels identified by the endoscopist

Secondary outcomes

  1. Vessel Detection Time (VDT)

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Abhishek Tyagi, M.S.

CONTACT

[email protected]

919989154556

Mohan Ramchandani, M.D.

CONTACT

[email protected]

919701335444

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Artificial Intelligence-Guided Detection of Anatomical Markers to Enhance Safety in Third-Space Endoscopic Procedures

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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