Plan A Occlusion and Reversal System Feasibility Study

September 13, 2026 updated by: Next Life Sciences

Prospective, Multicenter, Single-arm, Open Label, Interventional Clinical Trial Investigating the Safety and Effectiveness of the Plan A Male Contraceptive System.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. 40 men (all sites) will be enrolled and treated with Plan A occlusion (Vasalgel®) using DLAD (Delivery Lumen Access Device). The study will enroll into two groups. Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
  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 prior to initiation of any screening or study specific procedures
  3. 25 to 65 years of age at the time of consent
  4. Body Mass Index (BMI) <31 kg/m2
  5. Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
  6. Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
  7. In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception
  8. Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy
  9. Lives in close proximity to the trial site to enable provision of fresh semen samples unless the subject agrees to provide semen samples at the trial site or laboratory

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 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. Recurrent pain with ejaculations
  4. Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
  5. 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
  6. History of prostatitis or benign prostatic hypertrophy requiring treatment
  7. Has undergone prior chemotherapy
  8. Has known current coagulopathy or other bleeding disorders
  9. Currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
  10. Subjects with cystic fibrosis
  11. Subjects with a history of inguinal hernia repair
  12. Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
  13. Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).
  14. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
  15. 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
  16. Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: Occlusion Procedure
This will be Group 1. Group1 will have the occlusion procedure but will not have the reversal procedure.
Device: Occlusion System
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel.
Experimental: Group 2: Reversal Procedure
This will be Group 2. Group 2 will have both the occlusion and reversal procedure.
Device: Occlusion System
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study subjects achieving azoospermia
Time Frame: Starting at the 30 day follow-up visit
Total number of subjects (N=40) achieving azoospermia
Starting at the 30 day follow-up visit
Study subjects that return to baseline semen levels
Time Frame: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
Total number of subjects (N=10) that return to baseline semen levels after reversal
Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
Adverse Events
Time Frame: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
Rate and severity of adverse events.
From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
Subject Comfort
Time Frame: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Subject Comfort Assessment Scale Post Occlusion and Reversal
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Histology
Time Frame: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
Excised portion of the vas deferens will be prepared with formalin for histological evaluation
From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject Satisfaction/Comfort Assessment
Time Frame: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Patient satisfaction questions along with NRS pain scale are being utilized to determine the comfort of the patient
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Next Life Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinico Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Homi Zargar, MD, Western Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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