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

NCT05134428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-11

No results posted yet for this study

Summary

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.

Conditions

  • Male Contraception
  • Healthy Male Adults

Interventions

DEVICE

ADAM System

The ADAM System consists of an injectable hydrogel and delivery apparatus that is intended to provide long-lasting, non-permanent vasal occlusion for men, resulting in azoospermia. ADAM is designed to be inserted into the vasa deferentia through a minimally invasive procedure, similar to the no-scalpel vasectomy.

Sponsors & Collaborators

  • Contraline, Inc

    lead INDUSTRY

Principal Investigators

  • Alex Pastuszak, MD, PhD · Contraline, Inc

  • Nathan Lawrentschuk, MB, BS, PhD, FRACS · Epworth Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2024-03-20
Completion
2026-03-08

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134428 on ClinicalTrials.gov