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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing gynecological surgical procedure with the anovo Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anovoâ„¢ Surgical System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate to open or laparoscopic approach | Procedure | |
| Rate of Unanticipated Adverse Device Effect | 8 Weeks Follow Up |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time (minutes) | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Learning Curve (surgery time against number of operations performed, considering frequency of cases and surgery difficulty) | 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) |
All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry.
Inclusion Criteria:
Exclusion Criteria:
-none
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All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry. To be eligible to participate in the registry, patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon H Branch | Contact | 9543033777 | sharon.branch@momentissurgical.com | |
| Matthew McKittrick | Contact | 6106745544 | matthew.mckittrick@momentissurgical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Recruiting | Celebration | Florida | 34747 | United States |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Procedure |
| Surgeon Safety Curve (cumulative UADEs against number of operations performed) | Procedure |
| User Skills Development Survey | Procedure |