Status:
COMPLETED
Anterior Orientation vs Posterior Orientation in Per Oral Endoscopic Myotomy POEM for the Treatment of Achalasia
Lead Sponsor:
NYU Langone Health
Conditions:
Achalasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the safety and efficacy of the anterior versus posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of Achalasia. The primary eff...
Detailed Description
Achalasia is one of the most studied esophageal motility disorders. The etiology of Achalasia is autoimmune, neurodegenerative, or viral immune. Achalasia is a consequence of the degeneration of gangl...
Eligibility Criteria
Inclusion
- Subjects who have been diagnosed with Achalasia Type I, II, or III by positive manometric findings and supporting findings by timed barium esophagram and endoscopy.
- Subjects who are willing and competent to sign Informed Consent and to comply with study related visits and procedures.
Exclusion
- Subjects who are under 18 years of age
- Subjects with Achalasia Type I, II, or III who have had a prior failed open or laparoscopic Heller myotomy; or have an esophageal diverticula, or anatomical variant dictating the approach of the myotomy
- Subjects diagnosed with other motility disorders such as distal esophageal spasm (DES), hypertensive peristalsis (Nutcracker), or hypercontractile esophagus (Jackhammer)
- Subjects with coagulopathy
- Pregnant females
- Subjects who in the investigators' opinion, are medically unstable , are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
- Subjects with decisional incapacity who are unable to comply with study related visits and procedures
Key Trial Info
Start Date :
July 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03228758
Start Date
July 24 2017
End Date
May 24 2019
Last Update
May 5 2020
Active Locations (1)
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1
NYU Winthrop Hospital
Mineola, New York, United States, 11501