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Procedure

Signati System for Vasectomy

N/A
Recruiting
Research Sponsored by Signati Medical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject is suitable to undergo a vasectomy as a long-term form of contraception
The subject is 25 to 65 years of age
Must not have
Subject has current coagulopathy or other bleeding disorders
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 months
Awards & highlights

Summary

This trial aims to test how safe and effective the Signati SeparoTM System is when used in general surgeries that involve cutting and tying blood vessels, like in a vasectomy procedure.

Who is the study for?
This clinical trial is for men seeking a vasectomy, which is a permanent form of birth control. Participants should be in good health and have decided not to father children in the future. Specific eligibility details are not provided but typically would exclude those with certain medical conditions or previous surgeries that could affect the procedure.
What is being tested?
The trial is testing the Signati Separo™ System, a new tool designed for surgical procedures like vasectomies. It seals vessels such as the vas deferens, which carries sperm from the testicles. The study aims to determine how safe and effective this system is when used for vasectomies.
What are the potential side effects?
While specific side effects are not listed, common risks associated with vasectomy procedures include pain, swelling, bruising at the surgery site, infection risk, and rare chances of chronic pain or sperm granuloma (a lump due to sperm leakage).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to have a vasectomy for contraception.
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I am between 25 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder or a condition that affects blood clotting.
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I am not on medication that affects sperm count or ejaculation.
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I have cystic fibrosis.
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I have testicular nodules or a history of active testicular or lower urinary tract cancer.
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I have used hormone therapy, like steroids or GnRH treatments, in the last 6 months.
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I have had a vasectomy or attempted to reverse a vasectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Secondary study objectives
Pain after procedure
Rate of subjects experiencing a complete ablation in the targeted area
Rate of successful vasectomy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device interventionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Signati Medical IncLead Sponsor
~5 spots leftby Sep 2025
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