Benign Prostatic HyperplasiaPhase 1NCT00468026
Evaluation of the ProstaPlant Prostate Stent Insertion in Ex Vivo Human Prostate
A Phase 1 study testing ProstaPlant Stent in people with Benign Prostatic Hyperplasia, run by ProstaPlant Urology System Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- ProstaPlant Stent
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Who may be able to join
- Males,
- 18 years old and up,
- Suffer from BPH,
- Candidate for radical prostatectomies
Who cannot join
- According to the physician's decision
Trial locations and contacts
1 site in 1 country.
Jack Baniel, Prof. contact
Israel1 site
"Asuta" Medical Center
Tel Aviv, 62748
Jack Baniel, Prof., 972-3-9376563
David Margel, Dr.
About this study
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- ProstaPlant Stent
- Keywords
- BPH, Prostate, Stent, Benign prostatic hyperplasia (BPH)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProstaPlant StentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- ProstaPlant Urology System Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jack Baniel, Prof., Principal investigator, "Rabin" Medical Center - "Belinson" Campus - Urology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468026
- Sponsor's protocol ID
- Human Ex-Vivo - V001-3.2007
- Status last verified
- Mar 2007
- First submitted
- 30 Apr 2007
- Last updated
- 1 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ProstaPlant Prostate Stent Insertion in Ex Vivo Human Prostate
- ClinicalTrials.gov ID
- NCT00468026
- Acronym / sponsor ID
- Human Ex-Vivo - V001-3.2007
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH, Prostate, Stent, Benign prostatic hyperplasia (BPH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- ProstaPlant Urology System Ltd.Industry (pharma, biotech, devices)
- First posted
- 1 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males,
- 18 years old and up,
- Suffer from BPH,
- Candidate for radical prostatectomies
Key exclusion criteria (1 listed)
- According to the physician's decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProstaPlant Stent | Device | – |
Primary outcome
This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Baniel, Prof. contact
Jack Baniel, Prof. principal investigator
"Rabin" Medical Center - "Belinson" Campus - Urology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ProstaPlant Stent in people with Benign Prostatic Hyperplasia, run by ProstaPlant Urology System Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack Baniel, Prof. (972-3-9376563), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2007.