Safety and Clinical Validation Study of the Plan A Delivery Lumen Access Device (DLAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Adverse Events
研究概览
简要总结
This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.
详细描述
This is a first in human research study, testing an investigational device which is being developed as part of a potential, non-hormonal, long-lasting, reversible male contraceptive system. The device is called the Delivery Lumen Access Device (DLAD) and it is intended to deliver a non-hormonal gel into the vas deferens to block the flow of sperm. Only the DLAD device is being tested in this study; the non-hormonal gel will not be administered. The purpose of this study is to confirm if the DLAD is safe to use and can access the vas deferens. The usability of the DLAD will also be assessed.
Up to 30 men, aged between 18 and 65 years, planning to undergo a vasectomy will be recruited for the study. Following a screening period of up to 30 days, eligible participants will undergo the DLAD procedure during their vasectomy. Post-procedure monitoring and recovery will be performed as per standard of care for a vasectomy procedure.
Participants will be contacted by telephone 14 days after the procedure to check for adverse events and changes in concomitant medications. If the investigator deems it necessary, the 14-day follow-up may be conducted in the clinic. At the investigator's discretion, participants may also be asked to attend unscheduled visits to assess adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 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 has already planned to undergo a vasectomy.
- •Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study before initiation of any screening or study-specific procedures.
- •18 to 65 years of age at the time of consent.
- •Good health for undergoing a vasectomy procedure as confirmed by medical history and physical examination.
- •In the opinion of the Investigator, the subject is suitable to undergo a vasectomy procedure as a form of long-term contraception.
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 an intrascrotal mass that would make the subject not suitable for the study.
- •Prior testicular surgery, testicular injury, or prior vasectomy with vasovasostomy (vasectomy reversal).
- •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 known current coagulopathy or other bleeding disorders.
- •Known allergy to DLAD materials including nickel, stainless steel and silicone.
- •Has cystic fibrosis.
- •Has history of inguinal hernia repair.
- •The subject belongs to a vulnerable population. Vulnerable subject populations are defined as individuals who are incarcerated, handicapped, have cognitive challenges, mental disability, persons in nursing homes, children, impoverished persons, homeless persons, economically or educationally disadvantaged persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces and persons kept in detention.
- •Currently participating in another study involving an investigational device or drug within the last 30 days prior to the first 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 DLAD product performance or interpretation of patient safety or study results.
结局指标
主要结局
Adverse Events
时间窗: 14 days post vasectomy procedure.
Treatment emergent adverse events
Adverse Events
时间窗: 14 days post vasectomy procedure.
Treatment emergent adverse events
次要结局
未报告次要终点