Plan A Occlusion and Reversal System Feasibility Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age25-65
SponsorNext Life Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
(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
Trial design
Treatments tested in this trial
- Occlusion System
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Next Life Sciences
Lead sponsor
Clinico Pty Ltd
Collaborator
Source ClinicalTrials.gov