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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02209337 |
Date of registration:
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03/08/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
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Scientific title:
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Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse |
Date of first enrolment:
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September 2014 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02209337 |
Study type:
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Interventional |
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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Hungary
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Israel
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Contacts
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Name:
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Gil Levi, Dr. |
Address:
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Telephone:
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Email:
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Affiliation:
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Mayanei HaYeshua Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient has signed the informed consent form and is willing to participate in the
clinical study and data collection.
2. Patient age is between 18 and 75 years old
3. POP-Q: Aa and/or Ba is at least -1
Exclusion Criteria:
1. Patient is pregnant or breastfeeding
2. Patient suffering from active infection (on antibiotic therapy)
3. Patient planning vaginal delivery
4. Patient had Previous vaginal mesh surgery
5. Patient is in high risk for surgery (evidence of clinically significant
cardiovascular, renal, hepatic or respiratory diseases).
6. Any condition that in the judgment of the investigators would interfere with the
subject's ability to provide informed consent, comply with study instructions, place
the subject at increased risk, or which might confound interpretation of study
results.
7. Malignancy .
8. Known hypersensitivity to PEEK and polypropylene materials.
9. Participation in another investigational trial that has not completed the primary
endpoint or interferes with study participation.
10. Tendency for hyper-scaring reaction
11. Diagnosed with mental or emotional disturbance.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anterior Vaginal Wall Prolapse
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Vaginal Apex/Uterine Prolapse
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Intervention(s)
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Device: SRS
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Primary Outcome(s)
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No device related serious adverse events
[Time Frame: up to 12 month]
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Secondary Outcome(s)
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Achieving normal urinary function
[Time Frame: up to 12 months]
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Improvement in POP-Q: points Aa and Ba
[Time Frame: up to 12 month]
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Improvement in POP-Q point C
[Time Frame: up to 12 months]
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Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)
[Time Frame: up to 12 months]
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Secondary ID(s)
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CD-14-005
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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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