NCT06564571

Brief Summary

The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 19, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 31, 2025

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

August 19, 2024

Last Update Submit

May 27, 2025

Conditions

Keywords

pancreatic diseasepancreatic cancerpancreatic cystartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Rate of detection pancreatic abnormalities by AI

    Ability of AI to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas.

    1 day

Secondary Outcomes (2)

  • Rate of detection pancreatic solid mass lesions by AI

    1 day

  • Rate of detection pancreatic cystic lesions by AI

    1 day

Study Arms (1)

Patients undergoing endoscopic ultrasound procedures

Patients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform.

Device: Patients undergoing endoscopic ultrasound procedures

Interventions

Patients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform.

Patients undergoing endoscopic ultrasound procedures

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient 18 years or over undergoing endoscopic ultrasound examination

You may qualify if:

  • Age ≥ 18 years
  • Any patient undergoing endoscopic ultrasound examination

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic DiseasesPancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System DiseasesCysts

Study Officials

  • Shyam Varadarajulu, MD

    Orlando Health, Digestive Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

January 19, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

May 31, 2025

Record last verified: 2024-08

Locations