Pivotal Study to Assess the Safety and Effectiveness of the iTind Device
NCT ID: NCT02506465
Last Updated: 2022-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
185 participants
INTERVENTIONAL
2015-07-31
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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iTind arm
iTind implant is implant during the study for 5-7 days.
iTIND
Temporary Implantable Nitinol Device (iTIND)
Sham arm
Foley catheter is used during the study
Sham Arm
Foley catheter will be placed and immediately removed.
Interventions
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iTIND
Temporary Implantable Nitinol Device (iTIND)
Sham Arm
Foley catheter will be placed and immediately removed.
Eligibility Criteria
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Inclusion Criteria
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
2. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
3. A post void residual (PVR) volume \> 250 ml measured by ultrasound or acute urinary retention
4. Compromised renal function (i.e., serum creatinine level \> 1.8 mg/dl, or upper tract disease);
5. Confirmed or suspected bladder cancer;
6. Recent (within 3 months) cystolithiasis or hematuria;
7. Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
8. An active urinary tract infection.
9. Enrolled in another treatment trial for any disease within the past 30 days.
10. 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;
11. Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
12. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
13. History of prostatitis within the past 5 years.
14. Median lobe obstruction of the prostate.
15. 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).
16. Any serious medical condition likely to impede successful completion of the study
17. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
18. Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period.
19. Baseline PSA ≥ 10 ng/ml.
20. Positive DRE.
21. Baseline PSA between 2.5-10 ng/ml and free PSA \< 25%, without a subsequent negative prostate biopsy.
50 Years
80 Years
MALE
No
Sponsors
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Medi-Tate Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sheldon Pike, MD
Role: PRINCIPAL_INVESTIGATOR
St. John's Hospital
Locations
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Clinical Research Center of Florida
Pompano Beach, Florida, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
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
Carolina Uro Research Center
Myrtle Beach, South Carolina, United States
CIUSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada
Toronto
Toronto, , Canada
Countries
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References
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Elterman D, Alshak MN, Martinez Diaz S, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terens W, Kohan A, Gonzalez R, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu L, Kaminetsky J, Chughtai B. An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device. J Endourol. 2023 Jan;37(1):74-79. doi: 10.1089/end.2022.0226. Epub 2022 Oct 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Company website
Other Identifiers
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MT-03
Identifier Type: -
Identifier Source: org_study_id
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