Anovo™ Surgical System - Registry Study

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).

Study Overview

• Status: Recruiting
• Conditions: GYN Disorders
• Intervention / Treatment: Device: anovo™ Surgical System

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Sharon H Branch; Phone Number: 9543033777; Email: sharon.branch@momentissurgical.com
• Study Contact Backup: Name: Matthew McKittrick; Phone Number: 6106745544; Email: matthew.mckittrick@momentissurgical.com

Study Locations

• United States
  • Florida
    • Celebration, Florida, United States, 34747
      • Recruiting
      • AdventHealth
      • Contact: Jenni Freed, BSN; Phone Number: 407-303-9989; Email: jenni.freed@adventhealth.com
      • Principal Investigator: Erica Stockwell, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Conversion rate to open or laparoscopic approach	Procedure
Rate of Unanticipated Adverse Device Effect	8 Weeks Follow Up

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgery time (minutes)	Procedure

Other Outcome Measures

Outcome Measure	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)	Procedure
Surgeon Safety Curve (cumulative UADEs against number of operations performed)		Procedure
User Skills Development Survey		Procedure

Collaborators and Investigators

• Sponsor: Momentis Surgical

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female
• Other Study ID Numbers: Momentis2023GYNRegistry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes