Bladder Neck ObstructionNCT01436877
Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
A study testing Insertion of Temporary Implantable Nitinol Device (TIND) in people with Bladder Neck Obstruction and Benign Prostate Hyperplasia, run by Medi-Tate Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for… Read more about this study
- Who is it for?
- Ages 50 to 95 years, men only
- Conditions the study is for
- Bladder Neck Obstruction, Benign Prostate Hyperplasia
- What is being tested?
- Insertion of Temporary Implantable Nitinol Device (TIND)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Sep 2016
- Phase
- Interventional
- 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 50 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main IC:
- Subject signed informed consent prior to the performance of any study procedures.
- Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
- IPSS symptom severity score ≥ 10.
- Peak urinary flow of < 12 ml/sec
- No pathology found with kidney US
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- Prostatic urethra length < 30 mm
- Prostate volume < 35 cc
- Normal Urinalysis and urine culture.
Who cannot join
- Main EC:
- Any prior prostate treatment
- Suspected or proved carcinoma of prostate
- Urethral stricture
- Urinary bladder stones
- Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy).
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- Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.
- Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.
- Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.
- Any serious medical condition likely to impede successful completion of the study
- Intraoperative EC:
- Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH
The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.
- Being tested
- Insertion of Temporary Implantable Nitinol Device (TIND)
- Keywords
- BPH, bladder neck obstruction, Bladder neck obstruction secondary to BPH
- Medical subject headings
- Urinary Bladder Neck Obstruction, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of Temporary Implantable Nitinol Device (TIND)Device
Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.
| Study group | Role | What they receive |
|---|---|---|
| device | Experimental | Insertion of Temporary Implantable Nitinol Device (TIND) Receives: Device: Insertion of Temporary Implantable Nitinol Device (TIND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related and unanticipated SAE
Device related and unanticipated SAEs will be followed. No such SAEs are expected.
Measured: At 3 months
Secondary outcomes (2)
Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects
Questionnaire of IPSS will be done in each visit.
Measured: At 3 months
Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects
Maximal uroflow will be measured in each visit
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Neck ObstructionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medi-Tate Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roy Farfara, MD, Principal investigator, Bnai Zion Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436877
- Sponsor's protocol ID
- MT-01
- Status last verified
- Dec 2018
- First submitted
- 14 Sep 2011
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH
- ClinicalTrials.gov ID
- NCT01436877
- Acronym / sponsor ID
- MT-01
- Keywords
- BPH, bladder neck obstruction, Bladder neck obstruction secondary to BPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medi-Tate Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Sep 2011 (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 study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| device | Experimental | Device: Insertion of Temporary Implantable Nitinol Device (TIND)Insertion of Temporary Implantable Nitinol Device (TIND) |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject signed informed consent prior to the performance of any study procedures.
- Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
- IPSS symptom severity score ≥ 10.
- Peak urinary flow of < 12 ml/sec
- No pathology found with kidney US
Key exclusion criteria (12 listed)
- Any prior prostate treatment
- Suspected or proved carcinoma of prostate
- Urethral stricture
- Urinary bladder stones
- Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy).
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 |
|---|---|---|
| Insertion of Temporary Implantable Nitinol Device (TIND)Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office. | Device | device |
Primary outcome
Device related and unanticipated SAE
Time frame: At 3 months
Device related and unanticipated SAEs will be followed. No such SAEs are expected.
2 secondary outcomes
Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects
Time frame: At 3 months
Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects
Time frame: At 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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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.
Roy Farfara, MD principal investigator
Bnai Zion Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of Temporary Implantable Nitinol Device (TIND) in people with Bladder Neck Obstruction and Benign Prostate Hyperplasia, run by Medi-Tate 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 21 Dec 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device related and unanticipated SAE (time frame: At 3 months). 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 21 Dec 2018.