Evaluation of a Novel Endoscopic Treatment for Achalasia

Study Overview
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Brief Summary
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This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.

Detailed Description
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This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.

Official Title
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Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)

Conditions
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Achalasia

Intervention / Treatment
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* Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm Ability to undergo general anesthesia The subject is > 18 yrs.of age Ability to give informed consent Exclusion Criteria: o Sigmoid achalasia Contraindicated for EGD Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: POEM procedure<br>An endoscopic surgical procedure for achalasia; Per-oral Endoscopic Esophagomyotomy (POEM)will be performed. The POEM procedure will be performed in the operating room under general anesthesia and a scope will then be inserted into your mouth and down your throat and measurements will be taken. With the use of this lighted flexible scope the surgeon will make a small incision in the inner lining of your esophagus (throat), create a tunnel and then cut the muscle between the esophagus (throat) and the stomach. The initial little opening will be closed with a small clip. This procedure will allow easier passage of food into the stomach. | Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)<br>* The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.<br>* Other names: POEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure | Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting. | Within the first 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysphagia