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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-EUS Patients | Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - June 2022. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Endoscopic ultrasound | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical success rates | Documentation of clinical success rates | October 2014 - June 2022 |
| Documentation of Safety | Number of subjects with Adverse Events; Type, frequency and intensity of adverse events | October 2014 - June 2022 |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures
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| Name | Affiliation | Role |
|---|---|---|
| Prashant Kedia, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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