Contraline, Inc
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.
Azoospermia
Oligospermia
ADAM System
Not Applicable
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 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Epworth HealthCare
E. Melbourne, Victoria, Australia, 3002