- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468026
Evaluation of the ProstaPlant Prostate Stent Insertion in Ex Vivo Human Prostate
April 30, 2007 updated by: ProstaPlant Urology System Ltd.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jack Baniel, Prof.
- Phone Number: 972-3-9376563
Study Locations
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Tel-Aviv, Israel, 62748
- "Asuta" Medical Center
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Contact:
- Jack Baniel, Prof.
- Phone Number: 972-3-9376563
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Sub-Investigator:
- David Margel, Dr.
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Sub-Investigator:
- Miriam Konichevky, Dr.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Males,
- 18 years old and up,
- Suffer from BPH,
- Candidate for radical prostatectomies
Exclusion Criteria:
- According to the physician's decision
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jack Baniel, Prof., "Rabin" Medical Center - "Belinson" Campus - Urology Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 30, 2007
First Submitted That Met QC Criteria
April 30, 2007
First Posted (Estimate)
May 1, 2007
Study Record Updates
Last Update Posted (Estimate)
May 1, 2007
Last Update Submitted That Met QC Criteria
April 30, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Human Ex-Vivo - V001-3.2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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