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Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by The Oregon Clinic.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
The Oregon Clinic
Information provided by:
The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT01302288
First received: February 23, 2011
Last updated: February 25, 2011
Last verified: October 2010
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Purpose
Achalasia is a primary esophageal motility disorder where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy, a novel therapeutic approach to overcome the need for invasive surgery.
| Condition | Intervention | Phase |
|---|---|---|
| Achalasia | Procedure: Per oral endolumenal myotomy | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia |
Resource links provided by NLM:
Further study details as provided by The Oregon Clinic:
Primary Outcome Measures:
- Esophageal function testing [ Time Frame: 6 months ]esophageal manometry test, pH test, upper endoscopy,barium swallow
Secondary Outcome Measures:
- Quality of life score [ Time Frame: 6 months ]quality of life questionaire
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: Per oral endolumenal myotomy
patient cohort having flexible endoscopic submucosal esophageal partial myotomy
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Candidate for elective Heller myotomy
- Ability to undergo general anesthesia
- Ability to give informed consent
Exclusion Criteria:
- Previous mediastinal or esophageal surgery
- Contraindications for EGD
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302288
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302288
Contacts
| Contact: Lee L Swanstrom, MD | 503 281 0561 | lswanstrom@aol.com |
Locations
| United States, Oregon | |
| Good Samaritan Hospital, Legacy Health System | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Contact: Lee L Swanstrom, MD 503-281-0561 lswanstrom@aol.com | |
| Sub-Investigator: Christy M Dunst, MD | |
| Sub-Investigator: Erwin Rieder, MD | |
| Sub-Investigator: Angi Gill, RN | |
Sponsors and Collaborators
The Oregon Clinic
More Information
Publications:
| Responsible Party: | Lee L. Swanstrom, MD, The Oregon Clinic |
| ClinicalTrials.gov Identifier: | NCT01302288 History of Changes |
| Other Study ID Numbers: |
LEG1056 |
| Study First Received: | February 23, 2011 |
| Last Updated: | February 25, 2011 |
Keywords provided by The Oregon Clinic:
|
endolumenal myotomy, per oral endoscopic myotomy |
Additional relevant MeSH terms:
|
Esophageal Achalasia Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017