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

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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.

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 Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

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

Locations
Israel
"Asuta" Medical Center Not yet recruiting
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
Principal Investigator: Jack Baniel, Prof. "Rabin" Medical Center - "Belinson" Campus - Urology Department

ClinicalTrials.gov Identifier: NCT00468026     History of Changes
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:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male