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

NCT ID: NCT01436877

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Neck Obstruction Benign Prostate Hyperplasia

Keywords

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BPH bladder neck obstruction Bladder neck obstruction secondary to BPH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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device

Insertion of Temporary Implantable Nitinol Device (TIND)

Group Type EXPERIMENTAL

Insertion of Temporary Implantable Nitinol Device (TIND)

Intervention Type DEVICE

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Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.

Interventions

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Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.

Intervention Type DEVICE

Eligibility Criteria

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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:
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medi-Tate Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roy Farfara, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center, Haifa, Israel

Locations

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Meir Medical center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MT-01

Identifier Type: -

Identifier Source: org_study_id