Status:
COMPLETED
Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
Lead Sponsor:
Medi-Tate Ltd.
Conditions:
Bladder Neck Obstruction
Benign Prostate Hyperplasia
Eligibility:
MALE
50-95 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benig...
Eligibility Criteria
Inclusion
- Main IC:
- Subject signed informed consent prior to the performance of any study procedures.
- Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
- IPSS symptom severity score ≥ 10.
- Peak urinary flow of \< 12 ml/sec
- No pathology found with kidney US
- Prostatic urethra length \< 30 mm
- Prostate volume \< 35 cc
- Normal Urinalysis and urine culture.
Exclusion
- Main EC:
- Any prior prostate treatment
- Suspected or proved carcinoma of prostate
- Urethral stricture
- Urinary bladder stones
- Serum prostate specific antigen level \> 4 ng/ml (unless proved to be carcinoma free by biopsy).
- Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.
- Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.
- Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.
- Any serious medical condition likely to impede successful completion of the study
- Intraoperative EC:
- Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01436877
Start Date
September 1 2011
End Date
September 1 2016
Last Update
December 21 2018
Active Locations (1)
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1
Meir Medical center
Kfar Saba, Israel