An interventional study of Insertion of Temporary Implantable Nitinol Device (TIND) in Bladder Neck Obstruction and Benign Prostate Hyperplasia, sponsored by Medi-Tate Ltd.. Completed at 1 site in Israel. Open to male participants aged 50 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-12-21.
Sponsored by Medi-Tate Ltd. (part of Olympus Corporation) · Not applicable, Interventional, and Treatment
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.
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's enrollment of 32 is below the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →Medi-Tate Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
First submitted before Medi-Tate Ltd. became part of Olympus Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Main IC:
Exclusion Criteria:
Main EC:
Intraoperative EC:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Insertion of Temporary Implantable Nitinol Device (TIND)
Device: 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 related and unanticipated SAE
Device related and unanticipated SAEs will be followed. No such SAEs are expected.
Time frame: At 3 months
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.
Time frame: 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
Time frame: At 3 months
The record gives a start of Sep 2011, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Urinary Bladder Neck Obstruction →