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

Benign Prostate Hyperplasia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506465
• Other study ID #: MT-03
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2018

Study information

• Verified date: February 2022
• Source: Medi-Tate Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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:

1. Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;

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.

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• iTIND
Temporary Implantable Nitinol Device (iTIND)

Procedure:
• Sham Arm
Foley catheter will be placed and immediately removed.

Locations

Country	Name	City	State
Canada	CIUSS de l'Estrie-CHUS	Sherbrooke	Quebec
Canada	Toronto	Toronto
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	Carolina Uro Research Center	Myrtle Beach	South Carolina
United States	Premier Urology Group	New York	New York
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Primier Medical Center	Poughkeepsie	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medi-Tate Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Month 3 Results in the IPSS Score in Both Arms.	Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.	3 months
Secondary	Qmax Measurement	Month 3 results in Qmax (maximum urinary flow rate)	3 months
Secondary	PVR	Month 3 results in PVR (post-void residual urine volume)	3 months
Secondary	IIEF Questionnaire	The International Index of Erectile Function score. Scale: minimum 6, maximum 75. Higher values are better. Month 3 results in IIEF.	3 months
Secondary	SHIM	The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM.	3 months

External Links

•   Company website