Healthy Male Adults ParticipantsNCT06891729
Plan A Novel Delivery Device Study
A study testing Delivery Lumen Access Device and DLAD in people with Healthy Male Adults Participants and Vasectomy, run by Next Life Sciences at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Adults Participants, Vasectomy
- What is being tested?
- Delivery Lumen Access Device and DLAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subject who has already planned to undergo a vasectomy.
- 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.
- 18 to 65 years of age at the time of consent.
- Good health for undergoing a vasectomy procedure as confirmed by medical history and physical examination.
- In the opinion of the Investigator, the subject is suitable to undergo a vasectomy procedure as a form of long-term contraception.
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 an intrascrotal mass that would make the subject not suitable for the study.
- Prior testicular surgery, testicular injury, or prior vasectomy with vasovasostomy (vasectomy reversal).
- 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.
- Has known current coagulopathy or other bleeding disorders.
- Known allergy to DLAD materials including nickel, stainless steel and silicone.
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- Has cystic fibrosis.
- Has history of inguinal hernia repair.
- 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.
- Currently participating in another study involving an investigational device or drug within the last 30 days prior to the first 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 DLAD product performance or interpretation of patient safety or study results.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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
- Being tested
- Delivery Lumen Access Device, DLAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery Lumen Access DeviceDevice
Delivery Lumen Access Device use prior to Vasectomy
DLADDevice
Participants will be exposed to the DLAD during their planned vasectomy
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | All participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy. Receives: Device: Delivery Lumen Access Device; Device: DLAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Treatment emergent adverse events
Measured: 14 days post vasectomy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start15 Mar 2025
- Primary completion29 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Male Adults ParticipantsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Responsible party
- Sponsor
- Investigators
- Darlene Walley, Study director, Next Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891729
- Sponsor's protocol ID
- CIP100
- Status last verified
- Nov 2025
- First submitted
- 8 Mar 2025
- Last updated
- 28 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Validation Study of the Plan A Delivery Lumen Access Device (DLAD)
- ClinicalTrials.gov ID
- NCT06891729
- Acronym / sponsor ID
- CIP100
- Conditions
- Healthy Male Adults Participants, Vasectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Next Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Posted 28 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Delivery Lumen Access Device, Device: DLADAll participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male subject who has already planned to undergo a vasectomy.
- 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.
- 18 to 65 years of age at the time of consent.
- Good health for undergoing a vasectomy procedure as confirmed by medical history and physical examination.
- In the opinion of the Investigator, the subject is suitable to undergo a vasectomy procedure as a form of long-term contraception.
Key exclusion criteria (13 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 an intrascrotal mass that would make the subject not suitable for the study.
- Prior testicular surgery, testicular injury, or prior vasectomy with vasovasostomy (vasectomy reversal).
- 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.
- Has known current coagulopathy or other bleeding disorders.
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 |
|---|---|---|
| Delivery Lumen Access DeviceDelivery Lumen Access Device use prior to Vasectomy | Device | Interventional Arm |
| DLADParticipants will be exposed to the DLAD during their planned vasectomy | Device | Interventional Arm |
Primary outcome
Adverse Events
Time frame: 14 days post vasectomy procedure.
Treatment emergent adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Darlene Walley study director
Next Life Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery Lumen Access Device and DLAD in people with Healthy Male Adults Participants and Vasectomy, run by Next Life Sciences at 2 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 14 days post vasectomy procedure.). 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 28 Nov 2025.