Benign ProstaticHyperplasia (BPH)NCT02639442
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
A study testing ClearRing™ in people with Benign ProstaticHyperplasia (BPH), run by ProArc Medical at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign ProstaticHyperplasia (BPH)
- What is being tested?
- ClearRing™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Latvia1 site
Department of Urology, Pauls Stradins Clinical University Hospital
Riga
About this study
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.
Read the 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.
- Conditions
- Benign ProstaticHyperplasia (BPH)
- Being tested
- ClearRing™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearRing™Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: ClearRing™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and severity of all treatment-related adverse events
Measured: up to 3 months after procedure day
Secondary outcomes (5)
Changes in Qmax
measured by Uroflowmetry
Measured: change from baseline until 3 months FU visit
Changes in Post Void Residual
measured by Ultra-Sound
Measured: change from baseline until 3 months FU visit
Changes in LUTS symptoms
evaluated by patient's questionnaires (IPSS)
Measured: change from baseline until 3 months FU visit
Changes in LUTS symptoms
evaluated by patient's questionnaires ( BPHII)
Measured: change from baseline until 3 months FU visit
Changes in LUTS symptoms
evaluated by patient's questionnaires ( IIEF)
Measured: change from baseline until 3 months FU visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign ProstaticHyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProArc Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639442
- Sponsor's protocol ID
- PA-CP-10
- Status last verified
- Mar 2023
- First submitted
- 17 Dec 2015
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02639442
- Acronym / sponsor ID
- PA-CP-10
- Conditions
- Benign ProstaticHyperplasia (BPH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- ProArc MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClearRing™ | Experimental | Device: ClearRing™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 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearRing™ | Device | ClearRing™ |
Primary outcome
The frequency and severity of all treatment-related adverse events
Time frame: up to 3 months after procedure day
5 secondary outcomes
Changes in Qmax
Time frame: change from baseline until 3 months FU visit
Changes in Post Void Residual
Time frame: change from baseline until 3 months FU visit
Changes in LUTS symptoms
Time frame: change from baseline until 3 months FU visit
Changes in LUTS symptoms
Time frame: change from baseline until 3 months FU visit
Changes in LUTS symptoms
Time frame: change from baseline until 3 months FU visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearRing™ in people with Benign ProstaticHyperplasia (BPH), run by ProArc Medical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency and severity of all treatment-related adverse events (time frame: up to 3 months after procedure day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.