Actively Recruiting
Plan A Occlusion and Reversal System Feasibility Study
Led by Next Life Sciences · Updated on 2026-01-22
40
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
N
Next Life Sciences
Lead Sponsor
C
Clinico Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.
CONDITIONS
Official Title
Plan A Occlusion and Reversal System Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male seeking and suitable for vasectomy as long-term contraception
- Signed informed consent form before any study procedures
- Aged 25 to 65 years
- Body Mass Index (BMI) less than 31 kg/m2
- Good health confirmed by medical history, physical exam, and lab tests
- Normal semen analysis based on two samples
- Investigator deems subject suitable for vasectomy
- Agreement to use effective contraception until vasectomy
- Lives near trial site or agrees to provide semen samples at site or lab
You will not qualify if you...
- Absence of one or both vasa or abnormal scrotal conditions making subject unsuitable
- Prior testicular surgery, injury, or vasectomy reversal
- Recurrent pain during ejaculation
- Known allergy to sulfur-containing products or severe reaction to implantable devices
- Current local genital infections unless resolved
- History of prostatitis or benign prostatic hypertrophy needing treatment
- Prior chemotherapy
- Known bleeding disorders
- Taking medications affecting sperm count or ejaculation
- Cystic fibrosis
- History of inguinal hernia repair
- Vulnerable subjects (e.g., cognitive challenges, incarcerated)
- Participation in other investigational studies within 30 days
- Site staff or family of site staff involved in study
- Investigator concerns about safety or compliance
- Any condition interfering with evaluation or safety interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Western Urology
Maribyrnong, Victoria, Australia, 3032
Actively Recruiting
Research Team
D
Darlene Walley R Chief Executive Officer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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