Prospective Evaluation of an Endoscopic Ultrasound (EUS)-Based Artificial Intelligence to Assist in the Deployment of Lumen Apposing Metal Stents for Gallbladder Drainage

NCT ID: NCT06981052

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-12

Study Completion Date

2025-12-31

Brief Summary

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Lumen apposing metal stents are now being used to help patients who suffer from cholecystitis (infection of the gallbladder), especially in cases where patients are not candidates for surgery. Lumen apposing metal stents are effective for draining the gallbladder, however, placement is technically challenging. Scientists have developed an artificial intelligence to aid doctors in the deployment of these stents into the gallbladder. The aim of this study is test the performance of an artificial intelligence in providing physicians accurate information for gallbladder drainage.

Detailed Description

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Conditions

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Cholecystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with gallbladders undergoing AI evaluation for stent deployment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old
* Anticipation that patient may undergo endoscopic ultrasound
* Gallbladder present

Exclusion Criteria

* Cholecystectomy
* No indication for endoscopic ultrasound
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Neil Marya

Assistant Clinical Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UMass Chan Medical School/Umass Memorial Health Care

Worcester, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neil B Marya (Assistant Clinical Professor of Medicine), MD

Role: CONTACT

508-334-1000

Facility Contacts

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Neil B Marya, MD

Role: primary

508-334-1000

Other Identifiers

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H00020934

Identifier Type: -

Identifier Source: org_study_id

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