Benign Prostatic Hyperplasia (BPH)NCT02145208
Study to Assess the Efficacy of Medi-Tate iTind Device
A study testing TIND System in people with Benign Prostatic Hyperplasia (BPH), run by Medi-Tate Ltd. at 8 sites in 5 countries.
Trial summary
The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- TIND System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Oct 2014to Nov 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject signed informed consent prior to the performance of any study procedures.
- Male with symptomatic BPH. IPSS symptom severity score above 10. Peak urinary flow of below 12 ml/sec
- Prostate volume below 75 ml
- Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
- Subject that able to complete the study protocol.
- Normal Urinalysis and urine culture
Who cannot join
- cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
- neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.;
- a post void residual (PVR) volume above 250 ml measured by ultrasound or acute urinary retention
- compromised renal function (i.e., serum creatinine level above 1.8 mg/dl, or upper tract disease);
- confirmed or suspected bladder cancer;
- recent (within 3 months) cystolithiasis or hematuria;
Show all 16Show fewer
- 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.
- previous 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 or radical pelvic surgery;
- previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
- 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).
- 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.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Switzerland2 sites
Kantonsspital Frauenfeld
Frauenfeld
Lausanne University Hospital
Lausanne
United Kingdom2 sites
Frimley Health NHS
London
University College Hospital
London
About this study
Official title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).
The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.
Read the detailed description
After screening , eligible patients will undergo an an implantation procedure (operative), using the iTind device.
Implantation will be performed according to the Instructions For Use.
Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath, under direct vision. Before retrieval the subject will be asked for subjective discomfort evaluation and level of urgency in the past days after device insertion, about any AE and then the device will be retrieved.
The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months post implantation with an optional extension of follow up period (up to 36 months). In the visits the following will be assessed: Uroflow and residual urine volume tests, AE recording, IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects, in the local languages.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- TIND System
- Keywords
- 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.
TIND SystemDevice
An implant
| Study group | Role | What they receive |
|---|---|---|
| Medi-Tate iTind | Experimental | TIND System Receives: Device: TIND System |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS
Change of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up.
IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
Measured: 6 months.
SAE
The incidence of unexpected serious adverse events related to Meditate iTind and/or implantation/retrieval procedures, as determined by the investigator and the study medical monitor.
Measured: 5-7 days
Secondary outcomes (1)
Urinary peak flow
Increase of maximal urinary peak flow
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 posted22 May 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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
- Model description
- iTind
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medi-Tate Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claude Schulman, MD, Principal investigator, Edith cavell clinic, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145208
- Sponsor's protocol ID
- MT-02
- Status last verified
- Apr 2022
- First submitted
- 20 May 2014
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).
- ClinicalTrials.gov ID
- NCT02145208
- Acronym / sponsor ID
- MT-02
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- BPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medi-Tate Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 22 May 2014 (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 study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.
Detailed description
After screening , eligible patients will undergo an an implantation procedure (operative), using the iTind device.
Implantation will be performed according to the Instructions For Use.
Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath, under direct vision. Before retrieval the subject will be asked for subjective discomfort evaluation and level of urgency in the past days after device insertion, about any AE and then the device will be retrieved.
The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months post implantation with an optional extension of follow up period (up to 36 months). In the visits the following will be assessed: Uroflow and residual urine volume tests, AE recording, IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects, in the local languages.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- iTind
| Arm | Type | Receives |
|---|---|---|
| Medi-Tate iTind | Experimental | Device: TIND SystemTIND System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject signed informed consent prior to the performance of any study procedures.
- Male with symptomatic BPH. IPSS symptom severity score above 10. Peak urinary flow of below 12 ml/sec
- Prostate volume below 75 ml
- Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
- Subject that able to complete the study protocol.
Key exclusion criteria (16 listed)
- cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
- neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.;
- a post void residual (PVR) volume above 250 ml measured by ultrasound or acute urinary retention
- compromised renal function (i.e., serum creatinine level above 1.8 mg/dl, or upper tract disease);
- confirmed or suspected bladder cancer;
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 |
|---|---|---|
| TIND SystemAn implant | Device | Medi-Tate iTind |
Primary outcome
IPSS
Time frame: 6 months.
Change of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up. IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
SAE
Time frame: 5-7 days
The incidence of unexpected serious adverse events related to Meditate iTind and/or implantation/retrieval procedures, as determined by the investigator and the study medical monitor.
1 secondary outcome
Urinary peak flow
Time frame: 12 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 11 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Claude Schulman, MD principal investigator
Edith cavell clinic, Belgium
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIND System in people with Benign Prostatic Hyperplasia (BPH), run by Medi-Tate Ltd. at 8 sites in 5 countries.
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 6 inclusion and 16 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Switzerland, United Kingdom, Italy, Spain. 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?
IPSS (time frame: 6 months.). The study lists 2 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 11 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.