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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. ;


Study Design


Related Conditions & MeSH terms


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

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