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



Status:Completed
Conditions:Hematology, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:50 - 80
Updated:12/21/2018
Start Date:October 2015
End Date:October 2018

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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)

The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as
compared to control group (catheter only).

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.

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.
We found this trial at
12
sites
Pompano Beach, Florida 33060
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Pompano Beach, FL
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Baltimore, Maryland 21204
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Baltimore, MD
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Brooklyn, New York 11215
Principal Investigator: Ivan Grundberger, MD
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Brooklyn, NY
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259 1st Street
Garden City, New York 11501
Principal Investigator: Aaron Katz, MD
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Garden City, NY
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Lawrence, New York 11559
Principal Investigator: Sheldon Pike, MD
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from
Lawrence, NY
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45-28 Parsons Boulevard
Long Island City, New York 11355
Principal Investigator: Alfred Kohan, MD
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from
Long Island City, NY
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227 East 30th Street
Manhattan, New York 10016
Principal Investigator: Jed Kaminetsky, MD
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from
Manhattan, NY
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Manhattan, New York
Principal Investigator: Bilal Chughtai, MD
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from
Manhattan, NY
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Myrtle beach, South Carolina
Principal Investigator: Neal Shore, MD
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Myrtle beach, SC
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776 East 3rd Avenue
New York, New York 07203
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from
New York, NY
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Poughkeepsie, New York
Principal Investigator: Evan Goldfischer, MD
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Poughkeepsie, NY
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580 Rue Bowen Sud
Sherbrooke, Quebec J1G 2E8
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from
Sherbrooke,
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