Benign Prostatic Hyperplasia (BPH)NCT04579913
A Multi-center, International Prospective Follow up Study
An observational study of Benign Prostatic Hyperplasia (BPH), run by Medi-Tate Ltd. at 5 sites in 2 countries.
Trial summary
The study objective is to assess the safety and efficacy of iTind three to five years following treatment. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound
- How many people
- 17 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 21 Dec 2020to 22 Apr 2021
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient who participated in the MT-03 study in the iTind arm who had not undergone an alternative procedure for BPH during the first 12 month follow-up period and who is willing to participate in the current follow up study.
Who may be able to join
- Subject signed informed consent form (ICF)
- Subject who had participated in the MT-03 study in the iTind arm
- Subject able to comply with the study protocol.
Who cannot join
- Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study
- Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Manhattan Medical research
Manhattan, New York, 10016
Premier Urology Group
New York, New York, 08857
Lenox Hill Hospital
New York, New York, 10075
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
About this study
Official title: A Multi-center, International Prospective Follow up Study to Assess the Safety and Efficacy of the iTind Procedure After Three to Five Years of Follow Up
The study objective is to assess the safety and efficacy of iTind three to five years following treatment.
Read the detailed description
This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasoundOther
Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests.
| Study group | Role | What they receive |
|---|---|---|
| iTind subjects | Patient who participated previously in the MT-03 study in the iTind arm Receives: Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
iTind Durability
The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.
Measured: 36 months post procedure
iTind Durability
The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.
Measured: 48 months post procedure
iTind Durability
The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.
Measured: 60 months post procedure
Secondary outcomes (9)
iTind Efficacy
Change from baseline in IPSS
Measured: 36 months post procedure
iTind Efficacy
Change from baseline in IPSS
Measured: 48 months post procedure
iTind Efficacy
Change from baseline in IPSS
Measured: 60 months post procedure
iTind Efficacy
Change from baseline in Qmax
Measured: 36 months post procedure
iTind Efficacy
Change from baseline in Qmax
Measured: 48 months post procedure
iTind Efficacy
Change from baseline in Qmax
Measured: 60 months post procedure
iTind Safety
Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study
Measured: 36 months post procedure
iTind Safety
Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study
Measured: 48 months post procedure
iTind Safety
Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study
Measured: 60 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start21 Dec 2020
- Primary completion12 Mar 2021
- Study completion22 Apr 2021
Why it stopped: Covid-19
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medi-Tate Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579913
- Sponsor's protocol ID
- MT-03A
- Status last verified
- Apr 2021
- First submitted
- 29 Sep 2020
- Last updated
- 29 Apr 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 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, International Prospective Follow up Study to Assess the Safety and Efficacy of the iTind Procedure After Three to Five Years of Follow Up
- ClinicalTrials.gov ID
- NCT04579913
- Acronym / sponsor ID
- MT-03A
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medi-Tate Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 8 Oct 2020 (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.
The study objective is to assess the safety and efficacy of iTind three to five years following treatment.
Detailed description
This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iTind subjects | – | Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasoundPatient who participated previously in the MT-03 study in the iTind arm |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient who participated in the MT-03 study in the iTind arm who had not undergone an alternative procedure for BPH during the first 12 month follow-up period and who is willing to participate in the current follow up study.
Key inclusion criteria (3 listed)
- Subject signed informed consent form (ICF)
- Subject who had participated in the MT-03 study in the iTind arm
- Subject able to comply with the study protocol.
Key exclusion criteria (2 listed)
- Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study
- Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.
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 |
|---|---|---|
| Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasoundAdministration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests. | Other | iTind subjects |
Primary outcome
iTind Durability
Time frame: 36 months post procedure
The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.
iTind Durability
Time frame: 48 months post procedure
The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.
iTind Durability
Time frame: 60 months post procedure
The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.
9 secondary outcomes
iTind Efficacy
Time frame: 36 months post procedure
iTind Efficacy
Time frame: 48 months post procedure
iTind Efficacy
Time frame: 60 months post procedure
iTind Efficacy
Time frame: 36 months post procedure
iTind Efficacy
Time frame: 48 months post procedure
iTind Efficacy
Time frame: 60 months post procedure
iTind Safety
Time frame: 36 months post procedure
iTind Safety
Time frame: 48 months post procedure
iTind Safety
Time frame: 60 months post procedure
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Company websiteLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia (BPH), run by Medi-Tate Ltd. at 5 sites in 2 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 3 inclusion and 2 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 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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: Covid-19). 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?
iTind Durability (time frame: 36 months post procedure). 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 29 Apr 2021.