Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia (POEM)
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|ClinicalTrials.gov Identifier: NCT01399476|
Recruitment Status : Recruiting
First Posted : July 21, 2011
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment|
|Achalasia||Procedure: Endoscopic Myotomy Procedure: Endoscopic Myotomy for treatment of achalasia|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
|Experimental: Endoscopic Myotomy||
Procedure: Endoscopic Myotomy
Patients will receive the surgical procedure described in the summary (POEM).
Other Name: POEMProcedure: Endoscopic Myotomy for treatment of achalasia
Other Name: POEM
- Improved quality of life as defined by survey pre and post surgery [ Time Frame: six months ]patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
- Negative pH test [ Time Frame: six months ]Patients will be required to have 24 hour pH testing after surgery.
- Bleeding [ Time Frame: 1 year ]recorded blood loss will be taken during surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399476
|Contact: Angi B Gill, RNfirstname.lastname@example.org|
|United States, Oregon|
|The Oregon Clinic||Recruiting|
|Portland, Oregon, United States, 97210|
|Contact: Angi B Gill, RN 503-281-0561 email@example.com|
|Principal Investigator: Lee L Swanstrom, MD|
|Principal Investigator:||Lee L Swanstrom, MD||The Oregon Clinic|