To collect Real-World Data (RWD) on the ongoing safety and effectiveness of the anovo Surgical system in transvaginal gynecological laparoscopic surgical procedures and to obtain information on the impact of the anovo Skills Development Pathway on user behavior and performance (where performance is measured by the learning curve of the surgeons and procedure outcomes).
Specific Aims: 1. To collect RWD from surgeons with varying experience and expertise on their learning curve and time to achieve competency, and as such assess the success of the Skills Development Pathway. 2. Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience. 3. Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.
Study Type
OBSERVATIONAL
Enrollment
300
The anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.
AdventHealth
Celebration, Florida, United States
RECRUITINGConversion rate to open or laparoscopic approach
Time frame: Procedure
Rate of Unanticipated Adverse Device Effect
Time frame: 8 Weeks Follow Up
Surgery time (minutes)
Time frame: Procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.