Anovo™ Surgical System - Registry Study
- Conditions
- GYN Disorders
- Interventions
- Device: anovo™ Surgical System
- Registration Number
- NCT05945433
- Lead Sponsor
- Momentis Surgical
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
- willing to complete post-operative questionnaire
-none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing gynecological surgical procedure with the anovo Surgical System anovo™ Surgical System -
- Primary Outcome Measures
Name Time Method Conversion rate to open or laparoscopic approach Procedure Rate of Unanticipated Adverse Device Effect 8 Weeks Follow Up
- Secondary Outcome Measures
Name Time Method Surgery time (minutes) Procedure
Trial Locations
- Locations (1)
AdventHealth
🇺🇸Celebration, Florida, United States