A First in Human Study, Evaluating the Safety and Efficacy of ADAM™ 1.0

Overview

This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 3 sites. This is a prospective, non-randomized, open label interventional trial.

The ADAM System consists of the ADAM Hydrogel and the ADAM Injector. The ADAM Hydrogel is a proprietary, injectable, co-polymer hydrogel designed to provide long-lasting, non-permanent vasal occlusion for men. The ADAM Injector automates the dose and speed at which the ADAM Hydrogel is delivered into the vas deferens. The vas deferens may be accessed using a minimally invasive no-scalpel technique. Once inserted into the lumen of the vas deferens, the hydrogel prevents sperm transport from the epididymis into the ejaculate. Subjects will be followed up to 24 months or until semen analysis is ≥ 15 million sperm/mLA second semen analysis may be required to confirm sperm concentration, this is to be requested at the discretion of the study investigator, the second sample must be collected ≥2 days and ≤10 days of the first). The 25 subjects will be enrolled as follows: A minimum of 3 and up to 13 in each cohort. The Cohorts will enroll in parallel. The DSMB will meet at various timepoints during the study to review the safety data from the subjects (up to the 30-day post implant visit), e.g. after the first 4-5 subjects in any given cohort. Appropriate action will be taken if any related event is observed. Pre-procedure, the subject will provide two separate semen samples for lab analysis, the results of which will be averaged. The duration between collection of both specimens will be ≥2 days and ≤7 days. This will determine baseline sperm count and eligibility for enrolment. All subjects who demonstrate azoospermia or virtual azoospermia post-procedure will be followed until the semen analysis at any designated timepoint/visit demonstrates a sperm concentration ≥ 15 million sperm/mLthe lower 5% reference limit according to the WHO Laboratory Manual for the Examination and Processing of Human Semen). The subject may subsequently undergo a second lab semen analysis within 2-10 days to confirm the sperm concentration (decided at the discretion of the study investigator). If the subject's sperm concentration is still not conclusive after the second analysis, they will remain on trial until conclusive results are achieved. The subject's participation in the study will end once their semen analysis demonstrates ≥ 15 million sperm/mL or at 24 months after ADAM implantation, whichever is sooner. Subjects who do not achieve azoospermia by month 12 will be exited from the study. For clarity, subjects will remain in the study for a minimum of 12 months whether or not they achieve azoospermia or until resolution of any adverse event. Subjects whose participation in the study ends will be offered a vasectomy. An alternative form of contraception will be required for the duration of the study regardless of whether the subject demonstrates azoospermia during the course of the study. Lab Samples: All lab samples will be destroyed as per the local lab standard policy. The samples will not be retained for any further analysis or research.

Conditions

Interventions

Eligibility

Locations (3)

Outcomes