Open-label, Dose Ranging, Multi-Centre, Prospective First in Human Study to Assess the Safety of the ADAM System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Adverse Events
研究概览
简要总结
This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 3 sites. This is a prospective, non-randomized, open label interventional trial.
详细描述
The ADAM System consists of the ADAM Hydrogel and the ADAM Injector. The ADAM Hydrogel is a proprietary, injectable, co-polymer hydrogel designed to provide long-lasting, non-permanent vasal occlusion for men. The ADAM Injector automates the dose and speed at which the ADAM Hydrogel is delivered into the vas deferens. The vas deferens may be accessed using a minimally invasive no-scalpel technique. Once inserted into the lumen of the vas deferens, the hydrogel prevents sperm transport from the epididymis into the ejaculate.
Subjects will be followed up to 24 months or until semen analysis is ≥ 15 million sperm/mLA second semen analysis may be required to confirm sperm concentration, this is to be requested at the discretion of the study investigator, the second sample must be collected ≥2 days and ≤10 days of the first).
The 25 subjects will be enrolled as follows:
A minimum of 3 and up to 13 in each cohort. The Cohorts will enroll in parallel.
The DSMB will meet at various timepoints during the study to review the safety data from the subjects (up to the 30-day post implant visit), e.g. after the first 4-5 subjects in any given cohort. Appropriate action will be taken if any related event is observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 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
- •The subject is male
- •Subject is 25 to 65 years of age
- •Subject has a normal semen analysis (≥ 15 million sperm/mL, ≥40% total motility) defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
- •Subject is suitable to undergo a vasectomy as a long-term form of contraception
- •Subject is legally competent
- •In the opinion of the Investigator, the subject is willing and able to comply with the protocol, return for all follow-up visits and complete all protocol assessments, which includes providing recurring semen samples
- •Subject agrees to use an alternative method of contraception with any female partner of reproductive age during the course of the study treatment until study exit occurs
- •Subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
- •The subject has been informed of the nature of the study, agrees to its provisions, and has willingly provided written informed consent, approved by the appropriate Human Research Ethics Committee (HREC)
排除标准
- •Potential subjects will be excluded if ANY of the following criteria apply:
- •Subject is participating in another interventional clinical trial currently or within the past 3 months from the time of screening
- •Subject has history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists and antagonists) within the past 6 months
- •Subject on exam has any of the following: vas 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
- •Subject has allergic reaction to polyethylene glycol (PEG) containing products or has had a prior severe allergic response to injectable or implantable devices
- •Subject has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be admitted after resolution of an acute infection
- •Subject has current coagulopathy or other bleeding disorders
- •Subject 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)
- •Subject had a previous successful or unsuccessful vasectomy or vasectomy reversal
- •Subject has any clinically significant abnormal findings or other findings identified by Investigator that would exclude the subject.
研究组 & 干预措施
ADAM Cohort 1
The first 5 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 5 subjects will then be followed up to 24 months or until their semen analyses is ≥ 15 million sperm/mL.
干预措施: ADAM System (Device)
ADAM Cohort 2
An additional 13 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL.
干预措施: ADAM System (Device)
ADAM Cohort 3
An additional 4 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL.
干预措施: ADAM System (Device)
ADAM Cohort 4
An additional 3 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL.
干预措施: ADAM System (Device)
结局指标
主要结局
Adverse Events
时间窗: 30 Days
The primary endpoint is the number of all treatment-emergent adverse events
次要结局
- Serious AEs(30 Days)
- Adverse Events of Interest(2 years)
- Azoospermia(2 years)