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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty swallowing due to certain conditions. The main question it aims to answer is: does pre-POEM testing help the physician choose how long to cut the muscle.
Participants will allow researchers to access their standard of care information in their medical record, complete questionnaires at up to 6 times over a 2-year period.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response-Overall | Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years. | From enrollment to Year 2 |
| Clinical Response-by Sex | Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years. | From enrollment to Year 2 |
| Clinical Response-by Race | Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years. | From Enrollment to Year 2 |
| Clinical Response-by Ethnicity | Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years. | From Enrollment to Year 2 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion:
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Achalasia, EGJOO, and other spastic motility disorders are relatively rare and have substantial quality of life implications (see Protocol and Research Strategy for details). Given the prevalence and severity of these conditions, it is uncommon for patients with symptoms to not seek some form of treatment. Thus, we expect much of the recruitment to occur directly from site clinics, which include prominent esophageal motility experts and have robust referral networks, as patients seek care. A review of POEM procedure logs from participating CCs reveals that likely eligible patients are on average about 55-65 years old. We anticipate that the ethnic and racial distribution of our study group will be similar to prior achalasia studies with 25% African American, 10% Hispanic and 65% Caucasian.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Yan, BS | Contact | 312-908-1723 | elizabeth.yan@northwestern.edu | |
| Yasmin Pina, BS | Contact | 312-503-6459 | yasmin.pina@northwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Not yet recruiting | Scottsdale | Arizona | 85259 | United States | |
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| University of California San Diego |
| Not yet recruiting |
| La Jolla |
| California |
| 92093 |
| United States |
| University of Colorado Denver | Not yet recruiting | Denver | Colorado | 80217 | United States |
| University of Florida | Not yet recruiting | Gainesville | Florida | 32611 | United States |
| Adventist Health System/Sunbelt, Inc | Not yet recruiting | Orlando | Florida | 32803 | United States |
| Emory University | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Johns Hopkins University | Not yet recruiting | Baltimore | Maryland | 21218 | United States |
| Washington University | Not yet recruiting | St Louis | Missouri | 63130 | United States |
| Weill Cornell Medical College | Not yet recruiting | New York | New York | 10065 | United States |
| Case Western Reserve University | Not yet recruiting | Cleveland | Ohio | 44106 | United States |
| Vanderbilt University Medical Center | Not yet recruiting | Nashville | Tennessee | 37232 | United States |
| Baylor Scott & White Health | Not yet recruiting | Dallas | Texas | 75204 | United States |
| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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