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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT02259283 |
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Date of registration:
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29/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia
POEM |
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Scientific title:
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Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02259283 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Alessandro Repici, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Clinico Humanitas |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 to 75 years
- Manometric diagnosis of achalasia
- Eckardt score more than 3
- Informed consent
Exclusion Criteria:
- Increased surgical risk for important comorbidities,
- Pseudoachalasia
- Mega-esophagus (more than 7 cm) and or sigmoid esophagus,
- Previous esophageal or gastric surgery (with the exception of gastric perforation)
- Inability of completing the questionnarie
- Inability to keep a commitment for follow-up
- Esophageal diverticulum
Age minimum:
18 Years
Age maximum:
75 Years
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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Device: Hybrid Knife
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Primary Outcome(s)
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Clinical Success
[Time Frame: 24 months]
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Feasibility
[Time Frame: 24 months]
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Secondary Outcome(s)
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Quality of Life
[Time Frame: 24 months]
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Reflux disease
[Time Frame: 24 months]
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Treatment failure
[Time Frame: 24 months]
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Adverse events
[Time Frame: 24 months]
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Efficacy
[Time Frame: 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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