VasectomyNCT06402773
A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy
A study testing The Signati Separo™ Vessel Sealing System in people with Vasectomy, run by Signati Medical Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Signati SeparoTM System when used in general surgical procedures where ligation and division of vessels are desired, such as the vas deferens. This study will evaluate the Signati SeparoTM System as a vasectomy device. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vasectomy
- What is being tested?
- The Signati Separo™ Vessel Sealing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must sign a written informed consent form
- The subject is male and in stable, monogamous, heterosexual relationship
- The subject is 25 to 65 years of age
- The subject has a normal semen analysis (≥ 10 million sperm/mL, ≥30% total motility) defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition).
- The subject is suitable to undergo a vasectomy as a long-term form of contraception
- The subject is legally competent
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- In the opinion of the investigator, the subject is willing and able to comply with the protocol, return for all follow-up visits and complete all protocol assessments, which includes providing recurring semen samples
- Subject agrees to use an alternative method of contraception with any female partner of reproductive age during the course of the study until study exit occurs
- The subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study
Who cannot join
- Subject is participating in another interventional clinical trial currently or within the past three months at the time of screening
- Subject has a history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists, and antagonists) within the past six months
- Subject on the exam has any of the following: vas 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 or any anatomical finding that the investigator deems not suitable for the study
- Subject has an allergic reaction to any of the components of the system
- The subject has local genital infections such as balanitis, scrotal skin infection, epididymitis, orchitis, or tender (inflamed) tip of the penis (Note: subject t may be enrolled after the resolution of an acute infection)
- Subject has current coagulopathy or other bleeding disorders
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- Subject 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)
- The subject had a previous successful or unsuccessful vasectomy or vasectomy reversal
- The subject has any clinically significant abnormal findings or other findings identified by the investigator that would exclude the subject
- The subject has a condition that in the opinion of the physician may impede wound healing (e.g., immunosuppression, severe diabetes, scarring condition)
- The subject has testicular nodules, history of active testicular cancer, or any active lower urinary tract cancer.
- The subject has cystic fibrosis
- The subject is identified as a member of a vulnerable subject populations, such as the incarcerated or cognitively impaired, since they may be unduly convinced to participate in a clinical study which may lead to compromising the ethical integrity of the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Signati SeparoTM System when used in general surgical procedures where ligation and division of vessels are desired, such as the vas deferens. This study will evaluate the Signati SeparoTM System as a vasectomy device.
Read the detailed description
This study is designed to be a prospective, non-randomized safety study of eight subjects treated at up to three clinical sites in the United States.
The primary objective of this study will be to evaluate procedural and post treatment safety and effectiveness of the Signati SeparoTM System treatment via the incidence of adverse events and evaluation of semen post-procedure.
This group of subjects will continue to be followed for safety and efficacy for 6 months.
- Conditions
- Vasectomy
- Being tested
- The Signati Separo™ Vessel Sealing System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Signati Separo™ Vessel Sealing SystemDevice
Vessel Sealing System
| Study group | Role | What they receive |
|---|---|---|
| Device intervention | Experimental | Not described Receives: Device: The Signati Separo™ Vessel Sealing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence, type, duration, severity, and relationship to the study device.
Measured: Through 6-months
Secondary outcomes (3)
Rate of successful vasectomy
Rate of successful vasectomy, defined by evaluating semen for azoospermia or rare non-motile sperm (RNMS, ≤100,000 non-motile sperm/mL).
Measured: 3, 6 months
Rate of subjects experiencing a complete ablation in the targeted area
Physician assessment of complete ablation
Measured: Day 1
Pain after procedure
Visual analogue scale 0-10 rating where 0 is no pain and 10 is worst pain
Measured: Through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start5 Apr 2024
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Signati Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402773
- Sponsor's protocol ID
- SIG202301
- Status last verified
- May 2025
- First submitted
- 29 Apr 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy
- ClinicalTrials.gov ID
- NCT06402773
- Acronym / sponsor ID
- SIG202301
- Conditions
- Vasectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Signati Medical IncIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the Signati SeparoTM System when used in general surgical procedures where ligation and division of vessels are desired, such as the vas deferens. This study will evaluate the Signati SeparoTM System as a vasectomy device.
Detailed description
This study is designed to be a prospective, non-randomized safety study of eight subjects treated at up to three clinical sites in the United States.
The primary objective of this study will be to evaluate procedural and post treatment safety and effectiveness of the Signati SeparoTM System treatment via the incidence of adverse events and evaluation of semen post-procedure.
This group of subjects will continue to be followed for safety and efficacy for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device intervention | Experimental | Device: The Signati Separo™ Vessel Sealing System |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject must sign a written informed consent form
- The subject is male and in stable, monogamous, heterosexual relationship
- The subject is 25 to 65 years of age
- The subject has a normal semen analysis (≥ 10 million sperm/mL, ≥30% total motility) defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition).
- The subject is suitable to undergo a vasectomy as a long-term form of contraception
Key exclusion criteria (13 listed)
- Subject is participating in another interventional clinical trial currently or within the past three months at the time of screening
- Subject has a history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists, and antagonists) within the past six months
- Subject on the exam has any of the following: vas 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 or any anatomical finding that the investigator deems not suitable for the study
- Subject has an allergic reaction to any of the components of the system
- The subject has local genital infections such as balanitis, scrotal skin infection, epididymitis, orchitis, or tender (inflamed) tip of the penis (Note: subject t may be enrolled after the resolution of an acute infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Signati Separo™ Vessel Sealing SystemVessel Sealing System | Device | Device intervention |
Primary outcome
Adverse Events
Time frame: Through 6-months
Incidence, type, duration, severity, and relationship to the study device.
3 secondary outcomes
Rate of successful vasectomy
Time frame: 3, 6 months
Rate of subjects experiencing a complete ablation in the targeted area
Time frame: Day 1
Pain after procedure
Time frame: Through 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Signati Separo™ Vessel Sealing System in people with Vasectomy, run by Signati Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Through 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.