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

April 30, 2007 updated by: ProstaPlant Urology System Ltd.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jack Baniel, Prof.
  • Phone Number: 972-3-9376563

Study Locations

  • Israel
      • Tel-Aviv, Israel, 62748
        • "Asuta" Medical Center
        • Contact:
          • Jack Baniel, Prof.
          • Phone Number: 972-3-9376563
        • Sub-Investigator:
          • David Margel, Dr.
        • Sub-Investigator:
          • Miriam Konichevky, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • According to the physician's decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProstaPlant Urology System Ltd.

Investigators

  • Principal Investigator: Jack Baniel, Prof., "Rabin" Medical Center - "Belinson" Campus - Urology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

April 30, 2007

First Posted (Estimate)

May 1, 2007

Study Record Updates

Last Update Posted (Estimate)

May 1, 2007

Last Update Submitted That Met QC Criteria

April 30, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Human Ex-Vivo - V001-3.2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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