Therapeutic EUS Registry (T-EUS)

November 14, 2024 updated by: Methodist Health System

Therapeutic Endoscopic Ultrasound (EUS) Registry

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, observational, medical chart review. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - May 2019. Those subjects will undergo no additional tests and procedures as part of this study.

In order to validate these procedures and broaden its use beyond tertiary centers, it is crucial to understand its efficacy and success rate. The objective of the study is to evaluate retrospectively and prospectively the efficacy and safety of T-EUS procedures.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • T-EUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success rates
Time Frame: October 2014 - June 2022
Documentation of clinical success rates
October 2014 - June 2022
Documentation of Safety
Time Frame: October 2014 - June 2022
Number of subjects with Adverse Events; Type, frequency and intensity of adverse events
October 2014 - June 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Prashant Kedia, MD, Methodist Dallas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030.GID.2019.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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