Therapeutic EUS Registry

NCT05233631 | Enrolling By Invitation

• 1 other identifier: 030.GID.2019.D
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of Therapeutic Endoscopic ultrasound (T-EUS) . The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

Conditions

Gastrointestinal Disease

Outcome Measures

Primary Outcomes (2)

• clinical success rates

  Documentation of clinical success rates

  October 2014 - June 2022

• Documentation of Safety

  Number of subjects with Adverse Events; Type, frequency and intensity of adverse events

  October 2014 - June 2022

Study Arms (1)

T-EUS Patients

Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - June 2022.

Procedure: Therapeutic Endoscopic ultrasound

Interventions

Therapeutic Endoscopic ultrasound PROCEDURE

A minimally invasive procedure to assess digestive (gastrointestinal) and lung diseases. Procedure allows detailed imaging of the regional anatomy by approximating the frequency transducer to the region of interest.

Also known as: T-EUS

T-EUS Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures

You may qualify if:

• Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - May 2019
• Any patient who will undergo clinically indicated and/or standard of care T-EUS procedures from June 2019 - June 2027

You may not qualify if:

• Any patient who has not undergone endoscopic ultrasound would be excluded from the study.
• Below 18 years of age

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Prashant Kedia, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: February 10, 2022
• Study Start: June 12, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)