NCT05945433

Anovo™ Surgical System - Registry Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Momentis Surgical · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• GYN Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-28
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-07-14
• Last updated: 2023-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study