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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

ProstaPlant Stent

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring BPH, Prostate, Stent, Benign prostatic hyperplasia (BPH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

Inclusion Criteria:

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

Exclusion Criteria:

According to the physician's decision

Sites / Locations

"Asuta" Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00468026

First Posted

April 30, 2007

Last Updated

April 30, 2007

Sponsor

ProstaPlant Urology System Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00468026

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

ProstaPlant Urology System Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

BPH, Prostate, Stent, Benign prostatic hyperplasia (BPH)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

ProstaPlant Stent

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: Males, 18 years old and up, Suffer from BPH, Candidate for radical prostatectomies Exclusion Criteria: According to the physician's decision

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jack Baniel, Prof.

Phone

972-3-9376563

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack Baniel, Prof.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

"Asuta" Medical Center

City

Tel-Aviv

ZIP/Postal Code

62748

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jack Baniel, Prof.

Phone

972-3-9376563

First Name & Middle Initial & Last Name & Degree

David Margel, Dr.

First Name & Middle Initial & Last Name & Degree

Miriam Konichevky, Dr.

12. IPD Sharing Statement

Learn more about this trial

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

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