Study to Assess the Efficacy of Medi-Tate iTind Device

One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).

The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Device: TIND System

Detailed Description

After screening , eligible patients will undergo an an implantation procedure (operative), using the iTind device.

Implantation will be performed according to the Instructions For Use.

Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath, under direct vision. Before retrieval the subject will be asked for subjective discomfort evaluation and level of urgency in the past days after device insertion, about any AE and then the device will be retrieved.

The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months post implantation with an optional extension of follow up period (up to 36 months). In the visits the following will be assessed: Uroflow and residual urine volume tests, AE recording, IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects, in the local languages.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Edith Cavell
  • Gent, Belgium
    • Gent Hospital University
• Italy
  • Turin, Italy
    • San Orbessano
• Spain
  • Madrid, Spain
    • La Paz Hospital
• Switzerland
  • Frauenfeld, Switzerland
    • Kantonsspital Frauenfeld
  • Lausanne, Switzerland
    • Lausanne University Hospital
• United Kingdom
  • London, United Kingdom
    • Frimley Health NHS
  • London, United Kingdom
    • University College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject signed informed consent prior to the performance of any study procedures.
• Male with symptomatic BPH. IPSS symptom severity score above 10. Peak urinary flow of below 12 ml/sec
• Prostate volume below 75 ml
• 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)
• Subject that able to complete the study protocol.
• Normal Urinalysis and urine culture

Exclusion Criteria:

• cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
• neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.;
• a post void residual (PVR) volume above 250 ml measured by ultrasound or acute urinary retention
• compromised renal function (i.e., serum creatinine level above 1.8 mg/dl, or upper tract disease);
• confirmed or suspected bladder cancer;
• recent (within 3 months) cystolithiasis or hematuria;
• urethral strictures, bladder neck contracture, Urinary bladder stones
• or other potentially confounding bladder pathology;
• an active urinary tract infection.
• Enrolled in another treatment trial for any disease within the past 30 days.
• previous 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;
• previous pelvic irradiation or radical pelvic surgery;
• previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
• 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).
• Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.
• Any serious medical condition likely to impede successful completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medi-Tate iTind; TIND System	Device: TIND System; An implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPSS	Change of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up. IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.	6 months.
SAE	The incidence of unexpected serious adverse events related to Meditate iTind and/or implantation/retrieval procedures, as determined by the investigator and the study medical monitor.	5-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary peak flow	Increase of maximal urinary peak flow	12 months

Collaborators and Investigators

• Sponsor: Medi-Tate Ltd.
• Investigators: Principal Investigator: Claude Schulman, MD, Edith cavell clinic, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: MT-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No