Safety Evaluation of the ADAM System

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    25
  • sponsor
    Contraline, Inc
Updated on 30 April 2022
Accepts healthy volunteers

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.

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).

Details
Condition Azoospermia, Oligospermia
Treatment ADAM System
Clinical Study IdentifierNCT05134428
SponsorContraline, Inc
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
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