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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02506465
First Posted: July 23, 2015
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medi-Tate Ltd.
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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): NCT02506465


Locations
United States, Florida
Clinical Research Center of Florida
Pompano Beach, Florida, United States
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
United States, New York
Methodist Hospital
Brooklyn, New York, United States
Winthrop University
Garden City, New York, United States
St John's Episcopal
Lawrence, New York, United States
Integrated Medical Professionals
Long Island City, New York, United States
Manhattan Medical research
Manhattan, New York, United States
Weill cornell
Manhattan, New York, United States
Premier Urology Group
New York, New York, United States
Primier Medical Center
Poughkeepsie, New York, United States
United States, South Carolina
Carolina Uro Research Center
Myrtle Beach, South Carolina, United States
Canada, Quebec
CIUSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada
Canada
Toronto
Toronto, Canada
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
First Submitted: July 14, 2015
First Posted: July 23, 2015
Last Update Posted: September 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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