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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07399652
Enrollment
20
Registered
2026-02-10
Start date
2026-02-10
Completion date
2026-04-30
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia Cardia, Tumor

Keywords

Artificial Intelligence, Third Space Endoscopy, POEM, ESD, STER, EMR

Brief summary

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.

Detailed description

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.

Interventions

DEVICEAI generated segmentation mask for sub-mucosal blood vessels

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

Sponsors

Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with Achalasia Cardia or neoplasms.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Vessel Detection Rate (VDR)3 monthsthe proportion of vessels identified by the endoscopist

Secondary

MeasureTime frameDescription
Vessel Detection Time (VDT)3 monthsThe latency between a vessel appearing in the field of view and its identification.

Countries

India

Contacts

CONTACTAbhishek Tyagi, M.S.
mr.tyagi@gmail.com919989154556
CONTACTMohan Ramchandani, M.D.
ramchandanimohan@gmail.com919701335444
PRINCIPAL_INVESTIGATORAbhishek Tyagi

Asian Intitute of Gastroenterology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026