Prospective, Multicenter, Single-arm, Open Label, Interventional Clinical Trial Investigating the Safety and Effectiveness of the Plan A Male Contraceptive System.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Study subjects achieving azoospermia
研究概览
简要总结
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.
详细描述
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens. 40 men (all sites) will be enrolled and treated with Plan A occlusion (Vasalgel®) using DLAD (Delivery Lumen Access Device). The study will enroll into two groups. Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
- •Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures
- •25 to 65 years of age at the time of consent
- •Body Mass Index (BMI) <31 kg/m2
- •Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
- •Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
- •In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception
- •Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy
- •Lives in close proximity to the trial site to enable provision of fresh semen samples unless the subject agrees to provide semen samples at the trial site or laboratory
排除标准
- •(On exam, has any of the following); one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study.
- •Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
- •Recurrent pain with ejaculations
- •Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
- •Has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection
- •History of prostatitis or benign prostatic hypertrophy requiring treatment
- •Has undergone prior chemotherapy
- •Has known current coagulopathy or other bleeding disorders
- •Currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
- •Subjects with cystic fibrosis
- •Subjects with a history of inguinal hernia repair
- •Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
- •Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).
- •Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
- •In the opinion of the Investigator, there are issues or concerns that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
- •Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
研究组 & 干预措施
Group 1: Occlusion Procedure
This will be Group 1. Group1 will have the occlusion procedure but will not have the reversal procedure.
干预措施: Occlusion System (Device)
Group 2: Reversal Procedure
This will be Group 2. Group 2 will have both the occlusion and reversal procedure.
干预措施: Occlusion System (Device)
结局指标
主要结局
Study subjects achieving azoospermia
时间窗: Starting at the 30 day follow-up visit
Total number of subjects (N=40) achieving azoospermia
Study subjects that return to baseline semen levels
时间窗: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
Total number of subjects (N=10) that return to baseline semen levels after reversal
Adverse Events
时间窗: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
Rate and severity of adverse events.
Subject Comfort
时间窗: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Subject Comfort Assessment Scale Post Occlusion and Reversal
Histology
时间窗: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
Excised portion of the vas deferens will be prepared with formalin for histological evaluation
次要结局
- Subject Satisfaction/Comfort Assessment(From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.)