BPHNCT03994263
A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI
A study testing ITind device implant in people with BPH, run by Medi-Tate Ltd. at 1 site in Germany.
Trial summary
A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH
- What is being tested?
- ITind device implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 18 Nov 2019to 18 Feb 2021
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject signed informed consent form (ICF)
- Age 40 and above- Male with symptomatic BPH.
- IPSS symptom severity score ≥ 13
- Peak urinary flow of < 12 ml/sec
- Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound - TRUS)
- Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation)
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- Subject able to comply with the study protocol
- Normal urinalysis and negative urine culture
- Subjects that are able to undergo MRI.
Who cannot join
- A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
- Confirmed or suspected bladder cancer;
- Recent (within 3 months) cystolithiasis or hematuria;
- Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
- An active urinary tract infection.
- Enrolled in another treatment trial for any disease within the past 30 days.
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- Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
- Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
- Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
- Median lobe obstruction of the prostate (larger than 1cm).
- Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years)
- Patient with renal dysfunction
- Any serious medical condition likely to impede successful completion of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kliniken Nordoberpfalz AG Klinik für Urologie, Kinderurologie und interdisziplinäres Prostatakarzinomzentrum
Weiden
About this study
Official title: A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)
A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI
Read the detailed description
Study Objective:
To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.
Efficacy Endpoints:
The endpoints of this study are:
- Decrease in transition zone volume
- Monitor size and location of ablative lesions
- Monitor change in time of lesions
- Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.
- Conditions
- BPH
- Being tested
- ITind device implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITind device implantDevice
device implanted for 5-7 days
| Study group | Role | What they receive |
|---|---|---|
| iTind arm | Experimental | ITind device implant Receives: Device: ITind device implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE rate
Incidence (% of subjects) and frequency (no. of events) of device related adverse events.
Measured: 12 months
Unexpected SAE
Incidence (% of subjects) and frequency (no. of events) of unexpected serious adverse events deemed as related to Meditate iTIND and/or to implantation/retrieval procedures.
Measured: 12 months
Device complications
Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start18 Nov 2019
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medi-Tate Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Bschleipfer, Prof., Principal investigator, Weiden Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994263
- Sponsor's protocol ID
- MT-09
- Status last verified
- Sep 2021
- First submitted
- 18 Jun 2019
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT03994263
- Acronym / sponsor ID
- MT-09
- Conditions
- BPH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medi-Tate Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 21 Jun 2019 (actual)
- 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.
A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI
Detailed description
Study Objective:
To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.
Efficacy Endpoints:
The endpoints of this study are:
- Decrease in transition zone volume
- Monitor size and location of ablative lesions
- Monitor change in time of lesions
- Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iTind arm | Experimental | Device: ITind device implantITind device implant |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject signed informed consent form (ICF)
- Age 40 and above- Male with symptomatic BPH.
- IPSS symptom severity score ≥ 13
- Peak urinary flow of < 12 ml/sec
- Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound - TRUS)
Key exclusion criteria (13 listed)
- A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
- Confirmed or suspected bladder cancer;
- Recent (within 3 months) cystolithiasis or hematuria;
- Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
- An active urinary tract infection.
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 |
|---|---|---|
| ITind device implantdevice implanted for 5-7 days | Device | iTind arm |
Primary outcome
AE rate
Time frame: 12 months
Incidence (% of subjects) and frequency (no. of events) of device related adverse events.
Unexpected SAE
Time frame: 12 months
Incidence (% of subjects) and frequency (no. of events) of unexpected serious adverse events deemed as related to Meditate iTIND and/or to implantation/retrieval procedures.
Device complications
Time frame: 12 months
Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for BPH
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ProVIDE Studies Post Exit Analysis
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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.
Thomas Bschleipfer, Prof. principal investigator
Weiden Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITind device implant in people with BPH, run by Medi-Tate Ltd. at 1 site in Germany.
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 13 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: stopped early, as of the sponsor's last update on 7 Oct 2021. 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 Germany. 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 was stopped early (reason given: low recruitment). Results are not available in the source record.
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?
AE rate (time frame: 12 months). The study lists 3 primary outcomes in all. 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 7 Oct 2021.