Plan A Novel Delivery Device Study

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

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.

Study Overview

• Status: Completed
• Conditions: Vasectomy; Healthy Male Adults Participants
• Intervention / Treatment: Device: Delivery Lumen Access Device; Device: DLAD

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Epworth Healthcare
• Canada
  • Quebec/Canada
    • Québec, Quebec/Canada, Canada, G1H7B5
      • VasectoPro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male subject who has already planned to undergo a vasectomy.
2. Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study before initiation of any screening or study-specific procedures.
3. 18 to 65 years of age at the time of consent.
4. Good health for undergoing a vasectomy procedure as confirmed by medical history and physical examination.
5. In the opinion of the Investigator, the subject is suitable to undergo a vasectomy procedure as a form of long-term contraception.

Exclusion Criteria:

1. On exam, has any of the following: one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or an intrascrotal mass that would make the subject not suitable for the study.
2. Prior testicular surgery, testicular injury, or prior vasectomy with vasovasostomy (vasectomy reversal).
3. Has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection.
4. History of prostatitis or benign prostatic hypertrophy requiring treatment.
5. Has known current coagulopathy or other bleeding disorders.
6. Known allergy to DLAD materials including nickel, stainless steel and silicone.
7. Has cystic fibrosis.
8. Has history of inguinal hernia repair.
9. The subject belongs to a vulnerable population. Vulnerable subject populations are defined as individuals who are incarcerated, handicapped, have cognitive challenges, mental disability, persons in nursing homes, children, impoverished persons, homeless persons, economically or educationally disadvantaged persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces and persons kept in detention.
10. Currently participating in another study involving an investigational device or drug within the last 30 days prior to the first screening.
11. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
12. In the opinion of the Investigator, there are issues or concerns that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
13. Has any condition that, in the opinion of the Investigator, would interfere with evaluation of DLAD product performance or interpretation of patient safety or study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Arm; All participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Treatment emergent adverse events	14 days post vasectomy procedure.

Collaborators and Investigators

• Sponsor: Next Life Sciences
• Collaborators: Southern Star Research
• Investigators: Study Director: Darlene Walley, Next Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Actual): June 29, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CIP100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes