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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00468026
Recruitment Status : Unknown
Verified March 2007 by ProstaPlant Urology System Ltd..
Recruitment status was:  Not yet recruiting
First Posted : May 1, 2007
Last Update Posted : May 1, 2007
Sponsor:
Information provided by:
ProstaPlant Urology System Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: ProstaPlant Stent Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Criteria

Inclusion Criteria:

  • Males,
  • 18 years old and up,
  • Suffer from BPH,
  • Candidate for radical prostatectomies

Exclusion Criteria:

  • According to the physician's decision
Contacts and Locations
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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): NCT00468026


Contacts
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Contact: Jack Baniel, Prof. 972-3-9376563

Locations
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Israel
"Asuta" Medical Center
Tel-Aviv, Israel, 62748
Contact: Jack Baniel, Prof.    972-3-9376563      
Sub-Investigator: David Margel, Dr.         
Sub-Investigator: Miriam Konichevky, Dr.         
Sponsors and Collaborators
ProstaPlant Urology System Ltd.
Investigators
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Principal Investigator: Jack Baniel, Prof. "Rabin" Medical Center - "Belinson" Campus - Urology Department
More Information
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ClinicalTrials.gov Identifier: NCT00468026    
Other Study ID Numbers: Human Ex-Vivo - V001-3.2007
First Posted: May 1, 2007    Key Record Dates
Last Update Posted: May 1, 2007
Last Verified: March 2007
Keywords provided by ProstaPlant Urology System Ltd.:
BPH
Prostate
Stent
Benign prostatic hyperplasia (BPH)
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases