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Enrolling by Invitation

NCT Number: NCT05233631

Therapeutic 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.

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Key information

Conditions

Gastrointestinal Disease Digestive System Diseases Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: T-EUS

Primary outcomes

  1. clinical success rates

    Time frame: October 2014 - June 2022

    Documentation of clinical success rates

  2. Documentation of Safety

    Time frame: October 2014 - June 2022

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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Therapeutic Endoscopic Ultrasound (EUS) Registry

Acronym: T-EUS

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2022
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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