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

This study is not yet open for participant recruitment.

Verified by ProstaPlant Urology System Ltd., March 2007

Sponsored by:	ProstaPlant Urology System Ltd.
Information provided by:	ProstaPlant Urology System Ltd.
ClinicalTrials.gov Identifier:	NCT00468026

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468026

Contacts

Contact: Jack Baniel, Prof.

972-3-9376563

Locations

Israel
"Asuta" Medical Center
Tel-Aviv, Israel, 62748

Sponsors and Collaborators

ProstaPlant Urology System Ltd.

Investigators

Principal Investigator:

Jack Baniel, Prof.

"Rabin" Medical Center - "Belinson" Campus - Urology Department

More Information

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

Keywords provided by ProstaPlant Urology System Ltd.:

BPH
Prostate
Stent
Benign prostatic hyperplasia (BPH)

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009