IDE trial of sealed vasectomy procedure hits enrollment goal

The target enrollment has been met in an investigational device exemption (IDE) trial (NCT06402773) evaluating the safety and efficacy of the Separo Vessel Sealing System for sealed vasectomy procedures, announced Signati Medical, the developer of the device, in a news release.¹

Final completionof the study is anticipated for December 2024.

“We are pleased to announce the completion of enrollment for this groundbreaking clinical trial,” said William Prentice, CEO of Signati Medical, in the news release.¹ “The participation of all 8 patients is a testament to the growing interest in faster and potentially less-burdensome vasectomy options.”

According to Signati Medical, the Separo device holds the potential to reduce procedure times, lessen the risk of bleeding and infection, offer a faster recovery time, and present a more minimally invasive option for patients compared with traditional vasectomy methods. The company explained in a prior news release, “This minimally invasive procedure utilizes the Signati Separo to seal the vas deferens, the tubes that carry sperm, in a mere 4 seconds per side.”²

The prospective, first-in-human trial of the device was initiated in April 2024² following IDE approval from the FDA in December 2023.³ In total, the study has enrolled 8 patients to assess the safety and efficacy of the device.

To be eligible for enrollment, patients needed to be aged 25 to 65; male; in a stable, monogamous, and heterosexual relationship; and have a normal semen analysis (≥ 10 million sperm/mL, ≥30% total motility) based on the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition).⁴

The primary outcome measure for the study is the incidence, type, duration, and severity of adverse events, as assessed through 6 months. Secondary outcome measures for the trial include the rate of successful vasectomy as determined by the evaluation of semen after the procedure, the rate of patients who experience a complete ablation in the targeted area, and pain following the procedure.

Final completion of the study is anticipated for December 2024. Signati Medical also announced that they plan to submit a complete data package to the FDA this year to support regulatory approval of the device in the US. According to the company, FDA approval would make the device “the first major advancement in vasectomy technology in over 4 decades.”¹

Principal investigator Matthew J. Mutter, MD, an associate professor of clinical urology at Louisiana State University Medical Center, concluded in the news release, “The Separo system has the potential to improve the vasectomy experience for both patients and physicians significantly. To date, I have been impressed with the device's ease of use, and we expect final results to be available by the end of the year.”¹

References

1. Signati Medical announces completion of enrollment in first-in-human clinical trial for groundbreaking sealed vasectomy procedure. News release. Signati Medical Inc. July 18, 2024. Accessed July 19, 2024. https://www.globenewswire.com/en/news-release/2024/07/18/2915476/0/en/Signati-Medical-Announces-Completion-of-Enrollment-in-First-in-Human-Clinical-Trial-for-Groundbreaking-Sealed-Vasectomy-Procedure.html

2. Signati Medical enrolls first patient in groundbreaking sealed vasectomy procedure trial. News release. Signati Medical. April 10, 2024. Accessed July 19, 2024. https://signatimed.com/signati-medical-enrolls-first-patient-in-groundbreaking-sealed-vasectomy-procedure-trial/

3. Signati Medical, Inc. receives FDA approval for IDE study. News release. Signati Medical. December 20, 2023. Accessed July 19, 2024. https://signatimed.com/signati-medical-inc-receives-fda-approval-for-ide-study/

4. A safety study in human subjects evaluating the use of the Signati System for vasectomy. ClinicalTrials.gov. Last updated May 7, 2024. Accessed July 19, 2024. https://clinicaltrials.gov/study/NCT06402773