Plan A Novel Delivery Device Study

NCT06891729 | Completed Results FDA Device

• 1 other identifier: CIP100
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Healthy Male Adults Participants; Vasectomy

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Treatment emergent adverse events

  14 days post vasectomy procedure.

Study Arms (1)

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.

Device: Delivery Lumen Access Device; Device: DLAD

Interventions

Delivery Lumen Access Device DEVICE

Delivery Lumen Access Device use prior to Vasectomy

Interventional Arm

DLAD DEVICE

Participants will be exposed to the DLAD during their planned vasectomy

Interventional Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Next Life Sciences: lead
• Southern Star Research: collaborator

Study Sites (2)

Epworth HealthCare

Melbourne, Victoria, 3002, Australia

Location

VasectoPro

Québec, Quebec/Canada, G1H7B5, Canada

Location

Limitations and Caveats

Due to the early stage in this clinical program the sample size was relatively small.

Results Point of Contact

• Title: Darlene Walley
• Organization: Next Life Sciences

darlene.walley@nextlifesciences.org

415-407-5229

Study Officials

• Darlene Walley

  Next Life Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 24, 2025
• Study Start: March 15, 2025
• Primary Completion: June 29, 2025
• Study Completion: June 30, 2025
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CA (1)