CompletedNot Applicable

Plan A Novel Delivery Device Study

Australia, Canada24 participantsStarted 2025-03-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Adverse Events

Timeframe: 14 days post vasectomy procedure.

Trial details

NCT IDNCT06891729

SponsorNext Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-29

Results submitted2025-10-25

View on ClinicalTrials.gov More Healthy Male Adults Participants trials