Therapeutic EUS Registry

• Conditions: Gastrointestinal Disease
• Interventions: Procedure: Therapeutic Endoscopic ultrasound

• Registration Number: NCT05233631
• Lead Sponsor: Methodist Health System

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.

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 Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T-EUS Patients	Therapeutic Endoscopic ultrasound	Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - June 2022.

Primary Outcome Measures

Name	Time	Method
clinical success rates	October 2014 - June 2022	Documentation of clinical success rates
Documentation of Safety	October 2014 - June 2022	Number of subjects with Adverse Events; Type, frequency and intensity of adverse events

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States