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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Vessel Sealing System
LSU Health
New Orleans, Louisiana, United States
Adverse Events
Incidence, type, duration, severity, and relationship to the study device.
Time frame: Through 6-months
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).
Time frame: 3, 6 months
Rate of subjects experiencing a complete ablation in the targeted area
Physician assessment of complete ablation
Time frame: Day 1
Pain after procedure
Visual analogue scale 0-10 rating where 0 is no pain and 10 is worst pain
Time frame: Through 6 months
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