FertilityPhase 2NCT07361120
Plan A Occlusion and Reversal System Feasibility Study
A Phase 2 study testing Occlusion System in people with Fertility and Fertility, Male, run by Next Life Sciences at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility, Fertility, Male, Healthy Male Adults
- What is being tested?
- Occlusion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Jan 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
- Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures
- 25 to 65 years of age at the time of consent
- Body Mass Index (BMI) <31 kg/m2
- Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
- Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
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- In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception
- Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy
- Lives in close proximity to the trial site to enable provision of fresh semen samples unless the subject agrees to provide semen samples at the trial site or laboratory
Who cannot join
- (On exam, has any of the following); one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study.
- Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
- Recurrent pain with ejaculations
- Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
- 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
- History of prostatitis or benign prostatic hypertrophy requiring treatment
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- Has undergone prior chemotherapy
- Has known current coagulopathy or other bleeding disorders
- Currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
- Subjects with cystic fibrosis
- Subjects with a history of inguinal hernia repair
- Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
- Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).
- Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
- 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
- Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Darlene Walley R Chief Executive Officer, PhD contact
3 sites in 2 countries
Australia2 sites, 2 recruiting
- Recruiting
Western Urology
Maribyrnong, Victoria, 3032
Homi Zargar, MD, +1 61 300 927 427, pa@homizargar.com.au
- Recruiting
Dr. Snip
St Kilda, Victoria, 3182
Sarah Demediuk, MD, 1300 377 647, sarah@drsnip.au
Canada1 site, 1 recruiting
- Not yet recruiting
Clinique de Vasectomie
Hawkesbury, Ontario, K6A 1A8
Jean Philippe-Bercier, MD, 613-762-0997, jeanphilippebercier@gmail.com
About this study
Official title: Prospective, Multicenter, Single-arm, Open Label, Interventional Clinical Trial Investigating the Safety and Effectiveness of the Plan A Male Contraceptive System.
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.
Read the detailed description
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. 40 men (all sites) will be enrolled and treated with Plan A occlusion (Vasalgel®) using DLAD (Delivery Lumen Access Device). The study will enroll into two groups. Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.
- Conditions
- Fertility, Fertility, Male, Healthy Male Adults
- Being tested
- Occlusion System
- Keywords
- Vasectomy, Fertility, Reproductive Health, Male Contraception, Vas Occlusion, No Scalpel Vasectomy,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusion SystemDevice
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Occlusion Procedure | Experimental | This will be Group 1. Group1 will have the occlusion procedure but will not have the reversal procedure. Receives: Device: Occlusion System |
| Group 2: Reversal Procedure | Experimental | This will be Group 2. Group 2 will have both the occlusion and reversal procedure. Receives: Device: Occlusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study subjects achieving azoospermia
Total number of subjects (N=40) achieving azoospermia
Measured: Starting at the 30 day follow-up visit
Study subjects that return to baseline semen levels
Total number of subjects (N=10) that return to baseline semen levels after reversal
Measured: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
Adverse Events
Rate and severity of adverse events.
Measured: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
Subject Comfort
Subject Comfort Assessment Scale Post Occlusion and Reversal
Measured: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Histology
Excised portion of the vas deferens will be prepared with formalin for histological evaluation
Measured: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
Secondary outcomes (1)
Subject Satisfaction/Comfort Assessment
Patient satisfaction questions along with NRS pain scale are being utilized to determine the comfort of the patient
Measured: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men (all sites) reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Next Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinico Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Homi Zargar, MD, Principal investigator, Western Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361120
- Sponsor's protocol ID
- CIP102
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-arm, Open Label, Interventional Clinical Trial Investigating the Safety and Effectiveness of the Plan A Male Contraceptive System.
- ClinicalTrials.gov ID
- NCT07361120
- Acronym / sponsor ID
- CIP102
- Conditions
- Fertility, Fertility, Male, Healthy Male Adults
- Keywords
- Vasectomy, Fertility, Reproductive Health, Male Contraception, Vas Occlusion, No Scalpel Vasectomy,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Next Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Clinico Pty Ltd
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. 40 men (all sites) will be enrolled and treated with Plan A occlusion (Vasalgel®) using DLAD (Delivery Lumen Access Device). The study will enroll into two groups. Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men (all sites) reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Occlusion Procedure | Experimental | Device: Occlusion SystemThis will be Group 1. Group1 will have the occlusion procedure but will not have the reversal procedure. |
| Group 2: Reversal Procedure | Experimental | Device: Occlusion SystemThis will be Group 2. Group 2 will have both the occlusion and reversal procedure. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
- Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures
- 25 to 65 years of age at the time of consent
- Body Mass Index (BMI) <31 kg/m2
- Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
Key exclusion criteria (16 listed)
- (On exam, has any of the following); one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study.
- Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
- Recurrent pain with ejaculations
- Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusion SystemThe occlusion system comprised of the Delivery Lumen Access Device and Vasalgel. | Device | Group 1: Occlusion Procedure, Group 2: Reversal Procedure |
Primary outcome
Study subjects achieving azoospermia
Time frame: Starting at the 30 day follow-up visit
Total number of subjects (N=40) achieving azoospermia
Study subjects that return to baseline semen levels
Time frame: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
Total number of subjects (N=10) that return to baseline semen levels after reversal
Adverse Events
Time frame: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
Rate and severity of adverse events.
Subject Comfort
Time frame: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Subject Comfort Assessment Scale Post Occlusion and Reversal
Histology
Time frame: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
Excised portion of the vas deferens will be prepared with formalin for histological evaluation
1 secondary outcome
Subject Satisfaction/Comfort Assessment
Time frame: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darlene Walley R Chief Executive Officer, PhD contact
Homi Zargar, MD principal investigator
Western Urology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Occlusion System in people with Fertility and Fertility, Male, run by Next Life Sciences at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darlene Walley R Chief Executive Officer, PhD (1-415-407-5229, darlene.walley@nextlifesciences.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study subjects achieving azoospermia (time frame: Starting at the 30 day follow-up visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.