Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
|ClinicalTrials.gov Identifier: NCT02639442|
Recruitment Status : Unknown
Verified September 2016 by ProArc Medical.
Recruitment status was: Recruiting
First Posted : December 24, 2015
Last Update Posted : September 27, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Benign ProstaticHyperplasia (BPH)||Device: ClearRing™||Phase 1 Phase 2|
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of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
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
- The frequency and severity of all treatment-related adverse events [ Time Frame: up to 3 months after procedure day ]
- Changes in Qmax [ Time Frame: change from baseline until 3 months FU visit ]measured by Uroflowmetry
- Changes in Post Void Residual [ Time Frame: change from baseline until 3 months FU visit ]measured by Ultra-Sound
- Changes in LUTS symptoms [ Time Frame: change from baseline until 3 months FU visit ]evaluated by patient's questionnaires (IPSS)
- Changes in LUTS symptoms [ Time Frame: change from baseline until 3 months FU visit ]evaluated by patient's questionnaires ( BPHII)
- Changes in LUTS symptoms [ Time Frame: change from baseline until 3 months FU visit ]evaluated by patient's questionnaires ( IIEF)
- Duration of Catheter use post procedure [ Time Frame: until 12 months post procedure ]
- Long term safety evaluation [ Time Frame: until 12 months post procedure ]AE collection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639442
|Contact: Shai Golan||SHAI@PROARCMEDICAL.COM|