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NCT00468026 Clinical Trial

Evaluation of the ProstaPlant Prostate Stent Insertion in Ex Vivo Human Prostate

Benign Prostatic Hyperplasia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00468026
Other study ID # Human Ex-Vivo - V001-3.2007
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received April 30, 2007
Last updated April 30, 2007

Study information
Verified date March 2007
Source ProstaPlant Urology System Ltd.
Contact Jack Baniel, Prof.
Phone 972-3-9376563
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this ex-vivo study is to evaluate the insertion procedure for the ProstaPlant implant in human prostates and the support that it supplies to the prostate.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Males,

- 18 years old and up,

- Suffer from BPH,

- Candidate for radical prostatectomies

Exclusion Criteria:

- According to the physician's decision

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• ProstaPlant Stent

Locations
Country Name City State
Israel "Asuta" Medical Center Tel-Aviv

Sponsors (1)
Lead Sponsor Collaborator
ProstaPlant Urology System Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained
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