Clinical Study for the Evaluation of the Safety and Initi... | NCT02639442

Studies
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia

NCT02639442

Sponsor

ProArc Medical

Status

Completed

Last Update Posted

Mar 20, 2023Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Benign ProstaticHyperplasia (BPH)

Interventions

ClearRing™

Countries

Israel
Latvia

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Jun 2018Actual

Completion Date

May 2019Actual

First Submitted Date

Dec 17, 2015

First Submission Date that Met QC Criteria

Dec 20, 2015

First Posted Date

Dec 24, 2015Estimated

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

Mar 16, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH.

During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses an electro-cutting blade to perform a circular and superficial incision, in which the implant is placed. Such an implant, with the shape of an open ring, expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.

Detailed Description

The proposed study will be conducted on BPH patients, candidates for TURP and will aim to evaluate the ability of the ClearRing™ to improve BPH symptoms while conforming to safety of the procedure.

In the proposed study the implants will be inserted by a dedicated delivery system with the aid of resectoscope. Electrical current will be administered by off-the-shelf CE Mark diathermy that passes through the system to cut and pave the ring course.

The proper positioning of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.

The delivery tool, the implants, resectoscope and the diathermy equipment will be supplied by ProArc Ltd.

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

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ClearRing™	Experimental	subjects will undergo general/spinal/local block anesthesia and cystoscopy and/or x-ray evaluation. One to three implants will be transplanted into the patient prostate, followed by cystoscopy for results evaluation	Device: ClearRing™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ClearRing™	Device		ClearRing™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The frequency and severity of all treatment-related adverse events		up to 3 months after procedure day

Secondary Outcomes

Measure	Description	Time Frame
Changes in Qmax	measured by Uroflowmetry	change from baseline until 3 months FU visit
Changes in Post Void Residual	measured by Ultra-Sound

Other Outcomes

Measure	Description	Time Frame
Duration of Catheter use post procedure		until 12 months post procedure
Long term safety evaluation	AE collection	until 12 months post procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male 50 years of age and up to 85 years old.
Diagnosed with symptomatic benign prostatic hyperplasia (BPH)
International Prostate Symptom Score (IPSS) >13
Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml)
Subject is in good general health.
Subject understands and has signed the study informed consent form.
PSA according to the American Urological Association) AUA) guideline.

Exclusion Criteria:

Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses.
Subject allergic to nickel or titanium
Concomitant participation in another study
Diagnosed with Cancer except of BCC or SCC of the skin
Any medical condition at the investigator discretion that may interfere with the procedure.
Patient with coagulopathy due to medications or congenital
Patient is taking steroids
Previous prostate surgery
Compromised renal function due to obstructive uropathy
Urinary Tract Infection (UTI)
Intravesical lobe (based on ultrasound and/or cystoscopy and/or medical history)
Prostate volume (based on Trans Rectal Ultrasound) > 80g
American Society of Anesthesiologists score (ASA)≥3
Known neurogenic bladder
Implanted electronic device such as pacemaker/CRT/ICD/DBS.
Recent myocardial infarction (less than three months)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Rambam MC		Haifa			Israel
Department of Urology, Pauls Stradins Clinical University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided