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

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ClinicalTrials.gov Identifier: NCT03994263
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Medi-Tate Ltd.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994263


Contacts
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Contact: Thomas Bschleipfer, Prof. 01727716627 Th.B@gmx.de

Sponsors and Collaborators
Medi-Tate Ltd.
Investigators
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Principal Investigator: Thomas Bschleipfer, Prof. Weiden Clinic

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Responsible Party: Medi-Tate Ltd.
ClinicalTrials.gov Identifier: NCT03994263     History of Changes
Other Study ID Numbers: MT-09
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Prostatic Hyperplasia
Prostatic Diseases
Genital Diseases, Male