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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: |
NCT03425240 |
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Date of registration:
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24/01/2018 |
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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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Intra-operative Neuromodulation of the Pelvic Plexus
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Scientific title:
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Intra-operative Neuromodulation of the Pelvic Plexus |
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Date of first enrolment:
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September 10, 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03425240 |
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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: Device Feasibility. 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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Greece
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Contacts
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Name:
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Constantinos A. Constantinides, 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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Laikon General Hospital of Athens |
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Name:
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Spyridon Skoufias, MD |
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Address:
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Telephone:
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spyskouf@hotmail.com |
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Email:
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spyskouf@hotmail.com |
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Affiliation:
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Name:
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Spyridon Skoufias, MD |
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Address:
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Telephone:
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spyskouf@hotmail.com |
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Email:
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spyskouf@hotmail.com |
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Affiliation:
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Name:
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Ioannis Adamakis, 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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Laikon General Hospital of Athens |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Scheduled for open radical prostatectomy procedure under total anesthesia.
- Age 40 to 75 years old.
- Able to read and understand patient information materials and willing to sign a
written informed consent.
Exclusion Criteria:
- Have been diagnosed with severe vasculogenic erectile dysfunction.
- Have a prior history of pelvic surgery, trauma or irradiation therapy.
- Have a penile prosthesis.
- Have been diagnosed with neurologic diseases that may negatively impact erectile
functions.
- Currently having an active implantable device (such as a pacemaker).
- Posses any other characteristics that, per the investigator's judgment, may increase
the risk or impair data collection for the procedure/study.
- Inability to provide a fully informed consent.
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Erectile Dysfunction
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Prostate Cancer
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Intervention(s)
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Device: Nerve Stimulation
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Primary Outcome(s)
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Penile circumference increase in millimeters.
[Time Frame: 5 minutes]
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Secondary Outcome(s)
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Anatomic location of stimulation site
[Time Frame: 5 to 15 minutes]
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Stimulation threshold in volts
[Time Frame: 5 to 15 minutes]
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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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