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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Occlusion System
DeviceThe occlusion system comprised of the Delivery Lumen Access Device and Vasalgel.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group 1: Occlusion ProcedureExperimental treatment 1 intervention
Group B: Group 2: Reversal ProcedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Study subjects achieving azoospermia
Total number of subjects (N=40) achieving azoospermia
Time frame
Starting at the 30 day follow-up visit2
Study subjects that return to baseline semen levels
Total number of subjects (N=10) that return to baseline semen levels after reversal
Time frame
Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up3
Adverse Events
Rate and severity of adverse events.
Time frame
From the first subjects screening visit through the last subjects 14 Day phone follow up visit.4
Subject Comfort
Subject Comfort Assessment Scale Post Occlusion and Reversal
Time frame
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.Secondary outcomes
1
Subject Satisfaction/Comfort Assessment
Patient satisfaction questions along with NRS pain scale are being utilized to determine the comfort of the patient
Time frame
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Next Life Sciences
Lead sponsor
Clinico Pty Ltd
Collaborator
Source ClinicalTrials.gov