A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI

A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)

A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI

Study Overview

• Status: Terminated
• Conditions: BPH
• Intervention / Treatment: Device: ITind device implant

Detailed Description

Study Objective:

To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.

Efficacy Endpoints:

The endpoints of this study are:

• Decrease in transition zone volume
• Monitor size and location of ablative lesions
• Monitor change in time of lesions
• Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Weiden, Germany
    • Kliniken Nordoberpfalz AG Klinik für Urologie, Kinderurologie und interdisziplinäres Prostatakarzinomzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject signed informed consent form (ICF)
• Age 40 and above- Male with symptomatic BPH.
• IPSS symptom severity score ≥ 13
• Peak urinary flow of < 12 ml/sec
• Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound - TRUS)
• Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation)
• Subject able to comply with the study protocol
• Normal urinalysis and negative urine culture
• Subjects that are able to undergo MRI.

Exclusion Criteria:

• A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
• 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 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;
• Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
• Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
• Median lobe obstruction of the prostate (larger than 1cm).
• 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)
• Patient with renal dysfunction
• 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: iTind arm; ITind device implant	Device: ITind device implant; device implanted for 5-7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE rate	Incidence (% of subjects) and frequency (no. of events) of device related adverse events.	12 months
Unexpected SAE	Incidence (% of subjects) and frequency (no. of events) of unexpected serious adverse events deemed as related to Meditate iTIND and/or to implantation/retrieval procedures.	12 months
Device complications	Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications	12 months

Collaborators and Investigators

• Sponsor: Medi-Tate Ltd.
• Investigators: Principal Investigator: Thomas Bschleipfer, Prof., Weiden Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): February 18, 2021

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MT-09

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No