Status:
COMPLETED
Efficacy & Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) in the Treatment of Patients With Achalasia
Lead Sponsor:
Winthrop University Hospital
Conditions:
Achalasia
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to learn about the safety and usefulness of a procedure called endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia. Achalasia is a disord...
Detailed Description
The safety of the procedure and feasibility of the study will be measured by improvement in subjects' symptoms score, decrease in LES pressure, as well as the number and severity of complications or a...
Eligibility Criteria
Inclusion
- Patients 18 years or older, male or female, belonging to any race or ethnic origin
- Patients with manometric positive diagnosis of achalasia, with corresponding symptoms of dysphagia, regurgitation of food or chest pain
- Patients who are willing and competent to sign Informed Consent and to comply with study related visits and procedures
Exclusion
- Patients who are below 18 years of age
- Presence of coagulopathy
- Pregnancy
- Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
- Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest such as employees of ERBE, USA.
Key Trial Info
Start Date :
April 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01438398
Start Date
April 8 2011
End Date
October 22 2015
Last Update
May 11 2017
Active Locations (1)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501