Actively Recruiting

Phase Not Applicable
All Genders
ID07399652

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

Led by Asian Institute of Gastroenterology, India · Updated on 2026-04-15

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new artificial intelligence (AI) tool designed to assist during third space endoscopic procedures, such as Endoscopic Submucosal Dissection (ESD) and Peroral Endoscopic Myotomy (POEM). These procedures treat gastrointestinal tumors and motility disorders but carry risks of bleeding and perforation if blood vessels under the mucosa are not properly identified and managed. This study aims to see if the AI can help endoscopists detect and outline blood vessels more accurately and quickly during live procedures, building on previous retrospective studies. The study uses an AI system integrated into the Olympus EVIS X1 endoscopy equipment to provide real-time visual overlays that highlight submucosal blood vessels. Participants will be randomly assigned to two groups: one where the endoscopist sees the AI-generated vessel segmentation mask during the procedure, and another where the endoscopist performs the procedure without AI assistance. The performance of vessel detection and timing will be recorded and compared with expert reviews after the procedure. Participants diagnosed with Achalasia Cardia or tumors will take part in this prospective trial. Researchers will evaluate how well the AI improves the Vessel Detection Rate (VDR) and Vessel Detection Time (VDT) during the first three months. Safety monitoring will focus on procedural outcomes related to vessel identification. The total participation time and detailed follow-up procedures are aligned with the study design to ensure comprehensive evaluation of the AI tool during these complex endoscopic procedures.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with Achalasia Cardia or neoplasms
Not Eligible

You will not qualify if you...

  • Patients with conditions unsuitable for third space endoscopy procedures, such as Candidiasis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Procedure duration as per clinical care

Participants undergo third-space endoscopy procedures where an AI device provides real-time visual segmentation masks highlighting blood vessels during the procedure.

1 procedure visit (in-person)

Follow-up

Duration - 3 months

Participants are monitored post-procedure to assess vessel detection rates and detection times over a 3-month period.

Periodic follow-up visits during 3 months

Trial Site Locations

Total: 1 location

1

Asian Institute of Gastroenterology

Hyderabad, Telangana, India, 500032

Actively Recruiting

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Research Team

A

Abhishek Tyagi, M.S.

M

Mohan Ramchandani, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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