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NCT05233631 Clinical Trial

Therapeutic EUS Registry

Gastrointestinal Disease Clinical Trial

— T-EUS  

Official title:
Therapeutic Endoscopic Ultrasound (EUS) Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05233631
Other study ID # 030.GID.2019.D
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 12, 2019
Est. completion date June 2024

Study information
Verified date June 2023
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 400
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 2022 Exclusion Criteria: - Any patient who has not undergone endoscopic ultrasound would be excluded from the study. - Below 18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

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