Anovo™ Surgical System - Registry Study

GYN Disorders Clinical Trial

Official title:

Anovo™ Surgical System - Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945433
• Other study ID #: Momentis2023GYNRegistry
• Status: Recruiting
• Start date: June 28, 2023
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Momentis Surgical
• Contact: Sharon H Branch
• Phone: 9543033777
• Email: sharon.branch[@]momentissurgical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• GYN Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	AdventHealth	Celebration	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Momentis Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Procedure
Other	Surgeon Safety Curve (cumulative UADEs against number of operations performed)		Procedure
Other	User Skills Development Survey		Procedure
Primary	Conversion rate to open or laparoscopic approach		Procedure
Primary	Rate of Unanticipated Adverse Device Effect		8 Weeks Follow Up
Secondary	Surgery time (minutes)		Procedure