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

NCT03994263 | Terminated

• 1 other identifier: MT-09
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

BPH

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

iTind arm

EXPERIMENTAL

ITind device implant

Device: ITind device implant

Interventions

ITind device implant DEVICE

device implanted for 5-7 days

iTind arm

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Male with symptomatic BPH
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medi-Tate Ltd.: lead

Study Sites (1)

Kliniken Nordoberpfalz AG Klinik für Urologie, Kinderurologie und interdisziplinäres Prostatakarzinomzentrum

Weiden, Germany

Location

Study Officials

• Thomas Bschleipfer, Prof.

  Weiden Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: November 18, 2019
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)