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NCT05134428 | Recruiting | Azoospermia


Safety Evaluation of the ADAM System
Sponsor:

Contraline, Inc

Brief Summary:

This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 2 sites. This is a prospective, non-randomized, open label interventional trial.

Condition or disease

Azoospermia

Oligospermia

Intervention/treatment

ADAM System

Phase

Not Applicable

Detailed Description:

There are two cohorts to monitor safety in this study: Cohort 1: The first 10 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 10 subjects will then be followed up to 36 months or until the average of two semen analyses is ≥ 15 million sperm/mL (the duration between collection of both specimens is ≥2 days and ≤7 days). Cohort 2: An additional 15 subjects will be enrolled and implanted with ADAM after the DSMB Safety Review of the first 10 subjects at 30 days. They will be followed up to 36 months or until the average of two semen analyses is ≥ 15 million sperm/mL (the duration between collection of both specimens is ≥2 days and ≤7 days).

Study Type : Interventional
Estimated Enrollment : 25 participants
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Open-label, Single Arm, Multi-Centre, Prospective First-in-Human Study to Assess the Safety of the ADAM™ System
Actual Study Start Date : April 7, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025
Arm Intervention/treatment

Experimental: ADAM System

All subjects who consent and meet inclusion and none of the exclusion will be enrolled and receive the ADAM System, which is a hydrogel device implanted into the vas deferens.

Device: ADAM System

Ages Eligible for Study: 25 Years to 65 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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) -
Exclusion Criteria
  • 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.

Safety Evaluation of the ADAM System

Location Details


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Safety Evaluation of the ADAM System

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Australia, Victoria

Epworth HealthCare

E. Melbourne, Victoria, Australia, 3002

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