A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI
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|ClinicalTrials.gov Identifier: NCT03994263|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|BPH||Device: ITind device implant||Not Applicable|
To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.
The endpoints of this study are:
- Decrease in transition zone volume
- Monitor size and location of ablative lesions
- Monitor change in time of lesions
- Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||April 2020|
Experimental: iTind arm
ITind device implant
Device: ITind device implant
device implanted for 5-7 days
- AE rate [ Time Frame: 12 months ]Incidence (% of subjects) and frequency (no. of events) of device related adverse events.
- Unexpected SAE [ Time Frame: 12 months ]Incidence (% of subjects) and frequency (no. of events) of unexpected serious adverse events deemed as related to Meditate iTIND and/or to implantation/retrieval procedures.
- Device complications [ Time Frame: 12 months ]Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994263
|Contact: Thomas Bschleipfer, Prof.||01727716627||Th.B@gmx.de|
|Principal Investigator:||Thomas Bschleipfer, Prof.||Weiden Clinic|