Trials / Terminated
TerminatedNCT03994263
A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI
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)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Medi-Tate Ltd. · Industry
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI
Detailed description
Study Objective: 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. Efficacy Endpoints: 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ITind device implant | device implanted for 5-7 days |
Timeline
- Start date
- 2019-11-18
- Primary completion
- 2021-02-18
- Completion
- 2021-02-18
- First posted
- 2019-06-21
- Last updated
- 2021-10-07
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03994263. Inclusion in this directory is not an endorsement.