The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia (POEM)
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|ClinicalTrials.gov Identifier: NCT01584635|
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : October 31, 2016
Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.
The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Peroral Endoscopic Myotomy (POEM)
Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia
Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia
In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit
- Number of participants with adverse events [ Time Frame: 5 years post surgery ]Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.
- Eckardt symptom score [ Time Frame: 5 years ]By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.
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): NCT01584635
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||David Katzka, MD||Mayo Clinic|