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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06891729




Registration number
NCT06891729
Ethics application status
Date submitted
8/03/2025
Date registered
24/03/2025

Titles & IDs
Public title
Plan A Novel Delivery Device Study
Scientific title
Safety and Clinical Validation Study of the Plan A Delivery Lumen Access Device (DLAD)
Secondary ID [1] 0 0
CIP100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Male Adults Participants 0 0
Vasectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Delivery Lumen Access Device
Treatment: Devices - DLAD

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.


Treatment: Devices: Delivery Lumen Access Device
Delivery Lumen Access Device use prior to Vasectomy

Treatment: Devices: DLAD
Participants will be exposed to the DLAD during their planned vasectomy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
14 days post vasectomy procedure.
Primary outcome [2] 0 0
Product Performance Measures
Timepoint [2] 0 0
Perioperative
Primary outcome [3] 0 0
Intraluminal access to the Vas Deferens
Timepoint [3] 0 0
Perioperative

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth HealthCare - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec/Canada

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Next Life Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Southern Star Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Darlene Walley
Address 0 0
Next Life Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06891729