Safety Evaluation of the ADAM System

Oligospermia Clinical Trial

Official title: Open-label, Single Arm, Multi-Centre, Prospective First-in-Human Study to Assess the Safety of the ADAM™ System

Status Active, not recruiting

Clinical Trial Summary

This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 60 healthy males at 3 sites. This is a prospective, non-randomized, open label interventional trial.

Clinical Trial Description

There are three cohorts to monitor safety in this study, each cohort will have 15 participants each:

• Cohort 1: The first 5 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 15 subjects will then be followed up to 24 months or until their semen analyses is ≥ 15 million sperm/mL.

• Cohort 2: An additional 15 subjects will be enrolled and implanted with ADAM after the DSMB Safety Review of the first 5 subjects at 30 days. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL.

• Cohort 3: An additional 15 subjects will be enrolled and implanted with ADAM after the DSMB Safety Review of the first 5 subjects at 30 days. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL.

• Cohort 4: An additional 15 subjects will be enrolled and implanted with ADAM after the DSMB Safety Review of the first 5 subjects at 30 days. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL. ;

Related Conditions & MeSH terms

• Azoospermia
• Oligospermia

• NCT number: NCT05134428
• Study type: Interventional
• Source: Contraline, Inc
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2022
• Completion date: June 30, 2025