Anovo™ Surgical System - Registry Study
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Specific Aims:
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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.
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Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience.
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Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients undergoing gynecological surgical procedure with the anovo Surgical System
|
Device: anovo™ Surgical System
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.
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Outcome Measures
Primary Outcome Measures
- Conversion rate to open or laparoscopic approach [Procedure]
- Rate of Unanticipated Adverse Device Effect [8 Weeks Follow Up]
Secondary Outcome Measures
- Surgery time (minutes) [Procedure]
Other Outcome Measures
- Surgeon Learning Curve (surgery time against number of operations performed, considering frequency of cases and surgery difficulty) [Procedure]
To be reported as a continuous curve (plot per surgeon), and as the mean difference in surgery times between during learning curve and after learning curve stages (stages defined as before the surgeon achieves a steady state surgical time and after the surgeon achieves the steady state)
- Surgeon Safety Curve (cumulative UADEs against number of operations performed) [Procedure]
- User Skills Development Survey [Procedure]
Eligibility Criteria
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:
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patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
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willing to complete post-operative questionnaire
Exclusion Criteria:
-none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AdventHealth | Celebration | Florida | United States | 34747 |
Sponsors and Collaborators
- Momentis Surgical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Momentis2023GYNRegistry