None listed
Conditions
Brief summary
This study will test the safety and effectiveness of ADAM™ 2.0, a new contraceptive device for men, in a group of 30 healthy males aged 25 to 55 who are considering a vasectomy. Researchers believe that ADAM™ 2.0 can block sperm flow safely and could offer a reliable, non-hormonal, non-permanent alternative to traditional vasectomy. Participants will be closely monitored to assess how well the device works and to ensure their safety. The study aims to gather valuable information on the potential of ADAM™ 2.0 as a long-term contraceptive solution for men. The study hypothesis is that implanting a pre-formed, water-soluble hydrogel into the vas deferens will effectively block sperm flow into the ejaculate, thereby reducing sperm counts to near zero and preventing pregnancies.
Interventions
ADAM™ 2.0 is a male contraceptive device designed to block sperm flow through the vas deferens as an alternative non-hormonal, non-permanent option to a traditional vasectomy. The intervention involves the implantation of a pre-formed hydrogel implant into the vas deferens. Delivered via a minimally invasive 15-30 minute procedure, similar to a non-scalpel vasectomy, performed by a urological surgeon with 10+ years of experience. All participating surgeons will receive 2 hours of hands-on device
ADAM™ 2.0 is a male contraceptive device designed to block sperm flow through the vas deferens as an alternative non-hormonal, non-permanent option to a traditional vasectomy. The intervention involves the implantation of a pre-formed hydrogel implant into the vas deferens. Delivered via a minimally invasive 15-30 minute procedure, similar to a non-scalpel vasectomy, performed by a urological surgeon with 10+ years of experience. All participating surgeons will receive 2 hours of hands-on device training 1 week prior to their first procedures, surgeons will be trained by Contraline’s chief medical officer and chief technology officer. The procedure can be carried out under local or general anaesthesia, depending on surgeon decision, and will be performed in a hospital environment with the entire procedure visit taking approximately 5 hours. Participants will have in-person visits with the investigator (30 minutes each) at screening, 14 days, 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months, as well as telephone visits with the study coordinator (10 minutes) at 7 days, 60 days, 4 months, 5 months, 7 months, 8 months, 9 months, 10 months, 11 month, 15 months and 21 months to monitor safety, effectiveness, and any potential complications. The intervention is standardized across participants. All visits will be used to assess the device's placement, monitor for side effects, and gather data on its long-term efficacy, with adherence to the protocol closely monitored through regular follow-ups and participant questionnaires.
Sponsors
Contraline Australia Pty Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Potential participants must meet ALL the following criteria to be eligible for enrolment into the study: 1. Participant is male. 2. Participant is 25 to 55 years of age (at the time of consent). 3. Participant’s semen analysis meets the requirements from the World Health Organization (WHO) 6th Edition Laboratory Manual for the Examination and Processing of Human Semen): a. Semen volume =1.4 mL b. Sperm concentration =16 million/mL c. Total sperm number =39 million/ejaculate d. Progressive motility =30% e. Total motility =42% f. Normal morphology =4% g. Vitality =54% live spermatozoa h. pH =7.2 Results are to be evaluated from 2 semen samples collected during the screening period, with each sample collected after =2 days and =7 days of refraining from ejaculation. The second sample must be collected within 10 days of the first sample, observing the required period of refraining from ejaculation. Both timing requirements (refraining from ejaculation and interval between samples) must be met for the participant to qualify for enrolment. Participants will not be permitted to repeat the screening semen analysis if the sample timing requirements are not met. 4. Participant is seeking and suitable to undergo a vasectomy as a long-term form of contraception. 5. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures. 6. In the opinion of the investigator, the participant 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. 7. Participant agrees to use an alternative method of contraception with any female partner of childbearing potential during the course of the study until study exit occurs. 8. Participant is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study. 9. The participant has been informed of the nature of the study, agrees to its provisions, and has willingly provided written informed consent.
Exclusion criteria
Potential participants will be excluded if ANY of the following criteria apply: 1. Participants who have previously participated in a trial involving ADAM™ or are currently enrolled in another interventional clinical trial or have participated in a trial within the 3 months prior to screening, will be excluded. 2. Participant has history of prior hormonal therapy use (eg, androgenic steroids, gonadotropin-releasing hormone agonists and antagonists) within the past 6 months from the screening visit. 3. Participant on exam has any of the following: vas not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intra-scrotal mass that would make the participant not suitable for the study. 4. Participant has a known allergic reaction to polyethylene glycol containing products or has had a prior severe allergic response to injectable or implantable devices. 5. Participant 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. 6. Participant has current coagulopathy or other bleeding disorders. 7. Participant currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (eg, anabolic steroids, chemotherapy, alpha blocker). 8. Participant had a previous successful or unsuccessful vasectomy or vasectomy reversal. 9. Participant has any clinically significant abnormal findings or other findings identified by the investigator that would exclude the participant. 10. Participant is without access to telephone and/or ability to gain technology access.
Outcome results
None listed