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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05945433
Study type Observational [Patient Registry]
Source Momentis Surgical
Contact Sharon H Branch
Phone 9543033777
Email sharon.branch@momentissurgical.com
Status Recruiting
Phase
Start date June 28, 2023
Completion date June 2026

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