Status:
WITHDRAWN
Prospective Collection of Outcome Data Post POEM-TIF Procedure
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Northwell Health
Conditions:
Achalasia
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Brief Summary
Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless ...
Eligibility Criteria
Inclusion
- Adult patient age greater than 18 years old
- Manometrically proven diagnosis of either type I or type II achalasia.
Exclusion
- Achalasia type III, or other esophageal dysmotility disorders.
- Completion of POEM with evidence of mucosal injury or compromise
- Previous surgery of the stomach such as sleeve gastrectomy, gastric bypass, Heller myotomy, partial or complete fundoplication, or partial/complete gastrectomy
- Esophageal lumen diameter greater than 4 cm
- Sigmoidization of the esophagus
- Large esophageal diverticula
- Known active gastroesophageal malignancy
- Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Acute gastrointestinal bleeding
- Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet \< 50,000
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 26 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04052581
Start Date
July 1 2023
End Date
July 26 2023
Last Update
July 28 2023
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