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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by ProstaPlant Urology System Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468026
First Posted: May 1, 2007
Last Update Posted: May 1, 2007
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.
Information provided by:
ProstaPlant Urology System Ltd.
  Purpose
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 Intervention Phase
Benign Prostatic Hyperplasia Device: ProstaPlant Stent Phase 1

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

Resource links provided by NLM:


Further study details as provided by ProstaPlant Urology System Ltd.:

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00468026     History of Changes
Other Study ID Numbers: Human Ex-Vivo - V001-3.2007
First Submitted: April 30, 2007
First Posted: May 1, 2007
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