Gastrointestinal Disease
Conditions
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.
Interventions
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.
Sponsors
Study design
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 2027
Exclusion criteria
* Any patient who has not undergone endoscopic ultrasound would be excluded from the study. * Below 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States