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

This study is currently recruiting participants.
Verified September 2011 by Meditate
Sponsor:
Information provided by (Responsible Party):
Meditate
ClinicalTrials.gov Identifier:
NCT01436877
First received: September 14, 2011
Last updated: September 18, 2011
Last verified: September 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Meditate:

Primary Outcome Measures:
  • Device related and unanticipated SAE [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]
    Device related and unanticipated SAEs will be followed. No such SAEs are expected.


Secondary Outcome Measures:
  • Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    Maximal uroflow will be measured in each visit


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436877

Contacts
Contact: Roy Farfara, MD +972 54 459 7701 roy.farfara@b-zion.org.il

Locations
Israel
Bnai Zion Medical Center Recruiting
Haifa, Norh of Israel, Israel, 31048
Contact: Roy Farfara, MD     +972 54 459 7701     roy.farfara@b-zion.org.il    
Contact: Ofer Nativ, MD     +972 50 6267296     ofer.nativ@b-zion.org.il    
Principal Investigator: Roy Farfara, MD            
Sponsors and Collaborators
Meditate
Investigators
Principal Investigator: Roy Farfara, MD Bnai Zion Medical Center, Haifa, Israel
  More Information

No publications provided

Responsible Party: Meditate
ClinicalTrials.gov Identifier: NCT01436877     History of Changes
Other Study ID Numbers: MT-01
Study First Received: September 14, 2011
Last Updated: September 18, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Meditate:
BPH
bladder neck obstruction
Bladder neck obstruction secondary to BPH

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

ClinicalTrials.gov processed this record on June 17, 2013