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

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ClinicalTrials.gov Identifier: NCT01436877
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Medi-Tate Ltd.

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.

Condition or disease Intervention/treatment Phase
Bladder Neck Obstruction Benign Prostate Hyperplasia Device: Insertion of Temporary Implantable Nitinol Device (TIND) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: device
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Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.



Primary Outcome Measures :
  1. Device related and unanticipated SAE [ Time Frame: At 3 months ]
    Device related and unanticipated SAEs will be followed. No such SAEs are expected.


Secondary Outcome Measures :
  1. Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects [ Time Frame: At 3 months ]
    Questionnaire of IPSS will be done in each visit.

  2. Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects [ Time Frame: At 3 months ]
    Maximal uroflow will be measured in each visit



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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436877


Locations
Israel
Meir Medical center
Kfar Saba, Israel
Sponsors and Collaborators
Medi-Tate Ltd.
Investigators
Principal Investigator: Roy Farfara, MD Bnai Zion Medical Center, Haifa, Israel

Responsible Party: Medi-Tate Ltd.
ClinicalTrials.gov Identifier: NCT01436877     History of Changes
Other Study ID Numbers: MT-01
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2015

Keywords provided by Medi-Tate Ltd.:
BPH
bladder neck obstruction
Bladder neck obstruction secondary to BPH

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Urinary Bladder Neck Obstruction
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases