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This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
This study will enroll 600 subjects over the next 4 to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophageal POEM | Data will be collected for patients under going standard of care Esophageal POEM (E-POEM) | ||
| Gastric POEM | Data will be collected for patients under going standard of care Gastric POEM (G-POEM) | ||
| Zenker's POEM | Data will be collected for patients under going standard of care Zenker's diverticulum POEM (Z-POEM) |
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| Measure | Description | Time Frame |
|---|---|---|
| Post procedural Reflux Rate | Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM | 12 months |
| Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis | The main outcome of the study is to evaluate the proportion of patients who have clinical response to GPOEM. Clinical response is measured by the validated symptom assessment tool (gastroparesis cardinal symptom index - GCSI). Patients with a decrease in GCSI by one or more point will be defined as having a clinical response. | 12 months |
| Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence | The main outcome of this study is to evaluate rate of recurrence of symptoms after Z-POEM for Zenker's diverticulum. Recurrence is defined as a return of patient's symptoms (dysphagia, odynophagia) at the time of clinic follow-up. | 12 months |
| Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility. | The main outcome measure is to evaluate the long-term efficacy of POEM for esophageal motility disorders. Efficacy or clinical response is usually assessed using the Eckardt score. An Eckardt score of < 3 is traditionally defined as treatment response following POEM. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patient who present to the Center for Interventional Endoscopy for standard of care POEM procedures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dennis Yang, MD | Contact | 407-303-2570 | Dennis.Yang.MD@adventhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Dennis Yang, MD | AdventHealth Orlando | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Orlando | Recruiting | Orlando | Florida | 32803 | United States |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| D015155 | Esophageal Spasm, Diffuse |
| D018589 | Gastroparesis |
| D003680 | Deglutition Disorders |
| D016672 | Zenker Diverticulum |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D013272 | Stomach Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D004936 | Diverticulum, Esophageal |
| D004240 | Diverticulum |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D020763 | Pathological Conditions, Anatomical |