Therapeutic Endoscopic Ultrasound (EUS) Registry

Methodist Health System1 site in 1 country400 target enrollmentJune 12, 2019

ConditionsGastrointestinal Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Disease
Sponsor: Methodist Health System
Enrollment: 400
Locations: 1
Primary Endpoint: clinical success rates
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 12, 2019

End Date

June 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Methodist Health System

Responsible Party

Sponsor

Eligibility Criteria

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