Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia (POEM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01399476|
Recruitment Status : Recruiting
First Posted : July 21, 2011
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: Endoscopic Myotomy Procedure: Endoscopic Myotomy for treatment of achalasia||Not Applicable|
|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: POEM
Procedure: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|