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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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12 December 2020 |
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Main ID: |
NCT03476265 |
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Date of registration:
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13/03/2018 |
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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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Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility
DYSMOSTIM |
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Scientific title:
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Evaluation of Gastroesophageal Reflux Disease - Health Related Quality of Life After Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motilitygus (IEM) |
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Date of first enrolment:
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May 1, 2017 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03476265 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Sebastian F Schoppmann, 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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Medical University of Vienna |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject is indicated for LES Stimulation and plans to undergo antireflux surgery.
- Subject is meeting the criteria of IEM (Chicago classification v3.0)
- Subject provides signed informed consent
Exclusion Criteria:
- Subject is within a vulnerable population or is unable to understand the informed
consent.
- Subject is unwilling to attend follow-up visits.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dysphagia
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Electrical Stimulation of the Lower Esophageal Sphincter
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Gastro Esophageal Reflux
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Quality of Life
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Intervention(s)
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Device: Electrical Stimulation of the Lower Esophageal Sphincter
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Primary Outcome(s)
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Change in patient's GERD-HRQL from baseline to 6 months.
[Time Frame: 6 months]
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Secondary Outcome(s)
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Change of number of reflux events >1minute and >5 minute duration from baseline to 6 months follow up
[Time Frame: 6 months]
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Change of pH-metry from baseline to 6 months follow up
[Time Frame: 6 months]
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Distal Contractile Integral
[Time Frame: 6 months]
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Secondary ID(s)
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AUT-DYSMOSTIM-01
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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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