Registry for the Anovo Surgical System in gynecological surgeries
Anovo™ Surgical System - Registry Study
This study is testing how safe and effective the Anovo Surgical System is for gynecological surgeries while looking at how different levels of surgeon experience affect outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | Female |
| Sponsor | Momentis Surgical Industry-sponsored |
| Locations | 1 site (Celebration, Florida) |
| Trial ID | NCT05945433 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the safety and effectiveness of the Anovo Surgical System used in transvaginal gynecological laparoscopic procedures. It will assess the learning curve and competency of surgeons through the Skills Development Pathway, collecting data from surgeons with varying levels of experience. The study will also analyze the relationship between adverse events and surgeon experience while enrolling a diverse patient population to minimize bias in evaluating the device's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing gynecological surgical procedures with the Anovo Surgical System who can provide informed consent.
Not a fit: Patients not receiving gynecological surgeries or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of gynecological surgeries using the Anovo Surgical System.
How similar studies have performed: While this study focuses on a specific device, similar observational studies have successfully gathered real-world data to improve surgical practices.
Eligibility criteria
Show full inclusion / exclusion criteria
All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry. Inclusion Criteria: * 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 Exclusion Criteria: -none
Where this trial is running
Celebration, Florida
- AdventHealth — Celebration, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Sharon H Branch
- Email: sharon.branch@momentissurgical.com
- Phone: 9543033777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.