Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
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|ClinicalTrials.gov Identifier: NCT01302288|
Recruitment Status : Unknown
Verified October 2010 by The Oregon Clinic.
Recruitment status was: Recruiting
First Posted : February 24, 2011
Last Update Posted : February 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: Per oral endolumenal myotomy||Phase 2|
In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from esophageal achalasia.
Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately.
Results will be compared to historical data of conventional Heller myotomies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2012|
- Procedure: Per oral endolumenal myotomy
patient cohort having flexible endoscopic submucosal esophageal partial myotomy
- Esophageal function testing [ Time Frame: 6 months ]esophageal manometry test, pH test, upper endoscopy,barium swallow
- Quality of life score [ Time Frame: 6 months ]quality of life questionaire
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): NCT01302288
|Contact: Lee L Swanstrom, MD||503 281 email@example.com|
|United States, Oregon|
|Good Samaritan Hospital, Legacy Health System||Recruiting|
|Portland, Oregon, United States, 97210|
|Contact: Lee L Swanstrom, MD 503-281-0561 firstname.lastname@example.org|
|Sub-Investigator: Christy M Dunst, MD|
|Sub-Investigator: Erwin Rieder, MD|
|Sub-Investigator: Angi Gill, RN|