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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by ProstaPlant Urology System Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
ProstaPlant Urology System Ltd.
ClinicalTrials.gov Identifier:
NCT00468026
First received: April 30, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00468026     History of Changes
Other Study ID Numbers: Human Ex-Vivo - V001-3.2007
Study First Received: April 30, 2007
Last Updated: April 30, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by ProstaPlant Urology System Ltd.:
BPH
Prostate
Stent
Benign prostatic hyperplasia (BPH)

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014