Endolumenal Partial Myotomy for Esophageal Motility Disorders
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01302301|
Recruitment Status : Unknown
Verified November 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|
|Esophageal Motility Disorders||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 primary esophageal motility disorders.
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 Atypical Primary Motility Disorders Such as Achalasia and Esophageal Spasm|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||November 2011|
- Procedure: Per oral endolumenal myotomy
flexible endoscopic submucosal esophageal partial myotomy
- Esophageal Function Tests [ Time Frame: 6 month ]upper endoscopy, barium swallow, esophageal manometry,ph Test
- 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): NCT01302301
|Contact: Lee L Swanstrom, MD||503 281 firstname.lastname@example.org|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Lee L Swanstrom, MD 503-281-0561 email@example.com|
|Sub-Investigator: Christy M Dunst, MD|
|Sub-Investigator: Erwin Rieder, MD|
|Sub-Investigator: Angi Gill, RN|