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NCT05147389 · ClinicalTrials.gov registry record

Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis

A clinical trial of Common Bile Duct Neoplasms and Non-Neoplastic Bile Duct Disorder, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas.

Completed
Registry status
170
Enrollment target
6
Study locations

NCT05147389 is a study of Common Bile Duct Neoplasms and Non-Neoplastic Bile Duct Disorder that has completed, run by Instituto Ecuatoriano de Enfermedades Digestivas. The registered enrollment target is 170 participants. The trial reports 6 study locations across 4 states.

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The verdict

NCT05147389, a study of Common Bile Duct Neoplasms and Non-Neoplastic Bile Duct Disorder, has completed, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas.

COMPLETED
Registry status
170 participants
Enrollment target
6
Study locations

Study Summary

Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools is almost exclusively for intrahepatic CCA (iCCA). Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions. In Ecuador, the investigators have recently proposed an AI model to classify bile duct lesions during real-time DSOC, which accurately detected malignancy patterns. This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with high DSOC experienced endoscopists.

Interventions

  • DIAGNOSTIC_TEST AI model classification
  • DIAGNOSTIC_TEST DSOC endoscopist experts' classification

Study Locations (6)

Texas

  • Baylor Saint Luke's Medical Center - Houston
  • Houston Methodist Hospital - Houston

Other

  • Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel (UZB)/Vrije Universiteit Brussel (VUB) - Brussels
  • Serviço de Endoscopía Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - São Paulo

New Jersey

  • Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University - New Brunswick

Guayas

  • Carlos Robles-Medranda - Guayaquil

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2020-10-01
Est. Completion 2022-05-01

What the Registry Record Tells You About NCT05147389

The ClinicalTrials.gov registry entry for NCT05147389 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Instituto Ecuatoriano de Enfermedades Digestivas, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Common Bile Duct Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which AI model classification is the first listed.

NCT05147389 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Texas, Other, New Jersey.

Frequently Asked Questions

What is clinical trial NCT05147389 about?

NCT05147389 is a clinical study titled "Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis". Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artifi...

What is the current status of trial NCT05147389?

This trial is currently completed. The enrollment target is 170 participants. The study started on 2020-10-01. Estimated completion is 2022-05-01.

What conditions does trial NCT05147389 study?

This clinical trial studies the following conditions: Common Bile Duct Neoplasms, Non-Neoplastic Bile Duct Disorder.

What interventions are being tested in trial NCT05147389?

The interventions under investigation include: AI model classification (DIAGNOSTIC_TEST), DSOC endoscopist experts' classification (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05147389?

This trial is sponsored by Instituto Ecuatoriano de Enfermedades Digestivas, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05147389 being conducted?

This trial has 6 study locations across New Jersey, Texas, Guayas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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