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Pivotal Study to Assess the Safety and Effectiveness of the iTIND Device

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Medi-Tate Ltd.
Sponsor:
Information provided by (Responsible Party):
Medi-Tate Ltd.
ClinicalTrials.gov Identifier:
NCT02506465
First received: July 14, 2015
Last updated: May 17, 2017
Last verified: September 2016
  Purpose
The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).

Condition Intervention Phase
Benign Prostate Hyperplasia Device: iTIND Procedure: Sham Arm Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTIND) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Resource links provided by NLM:


Further study details as provided by Medi-Tate Ltd.:

Primary Outcome Measures:
  • Primary efficacy [ Time Frame: 3 months ]
    BPH symptoms mesured by IPSS/ AUA-SI Score


Secondary Outcome Measures:
  • secondary safety [ Time Frame: 12 months ]
    safety mesured by vital signs and physical examinations


Estimated Enrollment: 150
Study Start Date: October 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iTIND arm
iTIND implant is implant during the study for 5-7 days.
Device: iTIND
Temporary Implantable Nitinol Device (iTIND)
Sham Comparator: Sham arm
Foley catheter is used during the study
Procedure: Sham Arm
Foley catheter will be placed and immediately removed.

Detailed Description:

Medi-Tate i-Temporary Implantable Nitinol Device (iTIND) is intended to treat subjects with symptomatic BPH.

A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria.

Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up.

iTIND Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject signed informed consent form (ICF)
  2. Age 50 and above
  3. Male with symptomatic BPH.
  4. IPSS symptom severity score ≥ 10
  5. Peak urinary flow of < 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial.
  6. Prostate volume between 25 ml to 75 ml (assessed by ultrasound)
  7. Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
  8. Subject able to comply with the study protocol
  9. Normal Urinalysis and urine culture

    Exclusion Criteria:

  10. Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
  11. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
  12. A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
  13. Compromised renal function (i.e., serum creatinine level > 1.8 mg/dl, or upper tract disease);
  14. Confirmed or suspected bladder cancer;
  15. Recent (within 3 months) cystolithiasis or hematuria;
  16. Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
  17. An active urinary tract infection.
  18. Enrolled in another treatment trial for any disease within the past 30 days.
  19. Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
  20. Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
  21. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  22. History of prostatitis within the past 5 years.
  23. Median lobe obstruction of the prostate.
  24. Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years).
  25. Any serious medical condition likely to impede successful completion of the study
  26. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
  27. Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period.
  28. Baseline PSA ≥ 10 ng/ml.
  29. Positive DRE.
  30. Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02506465

Contacts
Contact: Lihi Liviatan +972-54-3114797 lihi@medi-tate.com

Locations
United States, Florida
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States
Contact: Jordan Herman, MD         
United States, Maryland
Chesapeake Urology Research Associates Recruiting
Baltimore, Maryland, United States
Contact: William Dowling, MD         
United States, New York
Methodist Hospital Recruiting
Brooklyn, New York, United States
Principal Investigator: Ivan Grundberger, MD         
St John's Episcopal Recruiting
Lawrence, New York, United States
Principal Investigator: Sheldon Pike, MD         
Integrated Medical Professionals Recruiting
Long Island City, New York, United States
Principal Investigator: Alfred Kohan, MD         
Manhattan Medical research Recruiting
Manhattan, New York, United States
Principal Investigator: Jed Kaminetsky, MD         
Weill cornell Not yet recruiting
Manhattan, New York, United States
Principal Investigator: Bilal Chughtai, MD         
Premier Urology Group Recruiting
New York, New York, United States
Contact: William Terens, MD         
Primier Medical Center Recruiting
Poughkeepsie, New York, United States
Principal Investigator: Evan Goldfischer, MD         
Winthrop University Not yet recruiting
Rock Hill, New York, United States
Principal Investigator: Aaron Katz, MD         
United States, South Carolina
Carolina Uro Research Center Recruiting
Myrtle Beach, South Carolina, United States
Principal Investigator: Neal Shore, MD         
Canada, Quebec
CIUSS de l'Estrie-CHUS Recruiting
Sherbrooke, Quebec, Canada
Contact: Le-Mai Tu, MD         
Canada
Toronto Recruiting
Toronto, Canada
Contact: Dean Elterman, MD       Dean.Elterman@uhn.ca   
Sponsors and Collaborators
Medi-Tate Ltd.
Investigators
Principal Investigator: Sheldon Pike, MD St. John's Hospital
  More Information

Additional Information:
Responsible Party: Medi-Tate Ltd.
ClinicalTrials.gov Identifier: NCT02506465     History of Changes
Other Study ID Numbers: MT-03
Study First Received: July 14, 2015
Last Updated: May 17, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on June 23, 2017