NCT06891729

Plan A Novel Delivery Device Study

Safety and Clinical Validation Study of the Plan A Delivery Lumen Access Device (DLAD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Next Life Sciences · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.

Detailed description

This is a first in human research study, testing an investigational device which is being developed as part of a potential, non-hormonal, long-lasting, reversible male contraceptive system. The device is called the Delivery Lumen Access Device (DLAD) and it is intended to deliver a non-hormonal gel into the vas deferens to block the flow of sperm. Only the DLAD device is being tested in this study; the non-hormonal gel will not be administered. The purpose of this study is to confirm if the DLAD is safe to use and can access the vas deferens. The usability of the DLAD will also be assessed. Up to 30 men, aged between 18 and 65 years, planning to undergo a vasectomy will be recruited for the study. Following a screening period of up to 30 days, eligible participants will undergo the DLAD procedure during their vasectomy. Post-procedure monitoring and recovery will be performed as per standard of care for a vasectomy procedure. Participants will be contacted by telephone 14 days after the procedure to check for adverse events and changes in concomitant medications. If the investigator deems it necessary, the 14-day follow-up may be conducted in the clinic. At the investigator's discretion, participants may also be asked to attend unscheduled visits to assess adverse events.

Conditions

• Healthy Male Adults Participants
• Vasectomy

Interventions

Type	Name	Description
DEVICE	Delivery Lumen Access Device	Delivery Lumen Access Device use prior to Vasectomy
DEVICE	DLAD	Participants will be exposed to the DLAD during their planned vasectomy

Timeline

• Start date: 2025-03-15
• Primary completion: 2025-06-29
• Completion: 2025-06-30
• First posted: 2025-03-24
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

2 sites across 2 countries: Australia, Canada

Regulatory

• FDA-regulated device study