Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01436877

Enrollment

Registered

2011-09-20

Start date

2011-09-30

Completion date

2016-09-30

Last updated

2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia, Bladder Neck Obstruction

Keywords

BPH, bladder neck obstruction, Bladder neck obstruction secondary to BPH

Brief 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 few days and taken out some 5 days later in the doctors office.

Interventions

DEVICEInsertion 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Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 95 Years

Healthy volunteers

Inclusion criteria

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 * Prostatic urethra length \< 30 mm * Prostate volume \< 35 cc * Normal Urinalysis and urine culture.

Exclusion criteria

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). * 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

Design outcomes

Primary

Measure	Time frame	Description
Device related and unanticipated SAE	At 3 months	Device related and unanticipated SAEs will be followed. No such SAEs are expected.

Secondary

Measure	Time frame	Description
Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects	At 3 months	Questionnaire of IPSS will be done in each visit.
Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects	At 3 months	Maximal uroflow will be measured in each visit

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026