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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01405469 |
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Date of registration:
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26/05/2011 |
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Primary sponsor: |
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Public title:
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Endoscopic Peroral Myotomy for Treatment of Achalasia
POEM |
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Scientific title:
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Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01405469 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Thomas Roesch, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitätsklinikum Hamburg-Eppendorf |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and
esophago-gastro-duodenoscopy which are consistent with the diagnosis
- persons of age > 18 years with medical indication for surgical myotomy or Endoscopic
balloon dilatation
- Signed written informed consent.
Exclusion criteria:
- Patients with previous surgery of the stomach or esophagus
- Patients with known coagulopathy
- Previous achalasia-treatment with surgery
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
- Eosinophilic esophagitis
- Barrett's esophagus
- Pregnancy
- Stricture of the esophagus
- Malignant or premalignant esophageal lesion
- Candida esophagitis
- Hiatal hernia > 2cm
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Achalasia
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Intervention(s)
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Other: Peroral Endoscopic Myotomy
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Primary Outcome(s)
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Successful symptom relief based after Peroral Endoscopic Myotomy.
[Time Frame: Eckhard score at 3 month after therapy]
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Secondary Outcome(s)
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Reflux Symptoms
[Time Frame: Reflux symptoms at 3 month after therapy]
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Resting pressure of the lower esophageal sphincter
[Time Frame: Manometry at 3 month after therapy]
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Secondary ID(s)
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UKE Hamburg Endoscopy PV3725
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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