Therapeutic EUS Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapeutic Endoscopic ultrasound.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Therapeutic Endoscopic Ultrasound (EUS) Registry
Overview
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.
Interventions
- 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.
Primary outcome measures
- clinical success rates [Time frame: October 2014 - June 2022]
- Documentation of Safety [Time frame: October 2014 - June 2022]
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
Exclusion criteria
- Any patient who has not undergone endoscopic ultrasound would be excluded from the study.
- Below 18 years of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Methodist Dallas Medical Center — Dallas
Identifiers
NCT: NCT05233631 · 030.GID.2019.D