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

• ClinicalTrials.gov Identifier: NCT03994263
• Recruitment Status: Active, not recruiting
• First Posted: June 21, 2019
• Last Update Posted: February 24, 2021
• Sponsor: Medi-Tate Ltd.
• Information provided by (Responsible Party): Medi-Tate Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
BPH	Device: ITind device implant	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: November 18, 2019
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: iTind arm; ITind device implant	Device: ITind device implant; device implanted for 5-7 days

Outcome Measures

Primary Outcome Measures :

1. AE rate [ Time Frame: 12 months ]
   Incidence (% of subjects) and frequency (no. of events) of device related adverse events.
2. Unexpected SAE [ Time Frame: 12 months ]
   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.
3. Device complications [ Time Frame: 12 months ]
   Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male with symptomatic BPH
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Kliniken Nordoberpfalz AG Klinik für Urologie, Kinderurologie und interdisziplinäres Prostatakarzinomzentrum

Weiden, Germany

Sponsors and Collaborators

Medi-Tate Ltd.

Investigators

• Principal Investigator: Thomas Bschleipfer, Prof.; Weiden Clinic

More Information

• Responsible Party: Medi-Tate Ltd.
• ClinicalTrials.gov Identifier: NCT03994263
• Other Study ID Numbers: MT-09
• First Posted: June 21, 2019
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No