Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure (POEM)
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|ClinicalTrials.gov Identifier: NCT01873300|
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : April 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: Endoscopic Esophageal Myotomy||Phase 1 Phase 2|
The purpose of this research study is to find out more about a less invasive way of doing the surgical procedure (esophageal myotomy) to treat Achalasia.
Achalasia is a disease of the esophagus, where the lower esophageal sphincter fails to relax, causing difficulty in swallowing.
Esophageal myotomy (Heller myotomy) is surgically cutting the muscle fibers of the esophageal sphincter to allow passage of food into the stomach.
Esophageal myotomy is routinely done either by laparoscopic or open surgery. Laparoscopic surgery requires several (about 4 to 5) small incisions in the abdomen to allow the camera and surgical instruments to be introduced into the abdominal cavity to perform the myotomy. In open surgery, a 6- to 8-inch abdominal incision is made to gain access to the abdominal cavity to perform the myotomy.
Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions.
The researchers are investigating how safe Endoscopic Esophageal Myotomy is and how well it works. Additionally, the researchers will assess the level of pain and the amount of scarring subjects has after this surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Esophageal Myotomy for the Treatment of Achalasia|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: treatment group
Patients undergoing POEM procedure
Procedure: Endoscopic Esophageal Myotomy
Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.
- Improvement of quality of life and dysphagia symptoms [ Time Frame: 6 months ]Patients will be given a quality of life and dysphagia questionare before surgery and at 3 and 6 months after 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): NCT01873300
|United States, Massachusetts|
|Masschusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||David W Rattner, MD||Massachusetts General Hospital|
|Study Director:||Ozanan R Meireles, MD||Masschusetts General Hospital / Harvard Medical School|