Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- The frequency and severity of all treatment-related adverse events
研究概览
简要总结
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.
详细描述
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of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
The frequency and severity of all treatment-related adverse events
时间窗: up to 3 months after procedure day
次要结局
- Changes in LUTS symptoms(change from baseline until 3 months FU visit)
- Changes in Post Void Residual(change from baseline until 3 months FU visit)
- Changes in Qmax(change from baseline until 3 months FU visit)