A Prospective Study to Observe the Mechanism of Action of... | NCT03994263

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

NCT03994263

Sponsor

Medi-Tate Ltd.

Status

Terminated

Last Update Posted

Oct 7, 2021Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Interventions

ITind device implant

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low recruitment

Expanded Access Info

Start Date

Nov 18, 2019Actual

Primary Completion Date

Feb 18, 2021Actual

Completion Date

Feb 18, 2021Actual

First Submitted Date

Jun 18, 2019

First Submission Date that Met QC Criteria

Jun 20, 2019

First Posted Date

Jun 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2021

Last Update Posted Date

Oct 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
iTind arm	Experimental	ITind device implant	Device: ITind device implant

Name	Type	Description	Arm Group Labels	Other Names
ITind device implant	Device	device implanted for 5-7 days	iTind arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male with symptomatic BPH

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided