- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302301
Endolumenal Partial Myotomy for Esophageal Motility Disorders
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97213
- Recruiting
- Providence Portland Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Esophageal Function Tests
Time Frame: 6 month
|
upper endoscopy, barium swallow, esophageal manometry,ph Test
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life score
Time Frame: 6 months
|
quality of life questionaire
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROV10-117A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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