Actively Recruiting

FEMALE
Healthy Volunteers
ID05945433

Anovo174 Surgical System Registry Study for Gynecological Laparoscopic Procedures

Led by Momentis Surgical · Updated on 2023-07-14

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting Real-World Data (RWD) to study the ongoing safety and effectiveness of the anovo Surgical System during transvaginal gynecological laparoscopic surgeries. They are also evaluating how the anovo Skills Development Pathway affects surgeon behavior and performance, focusing on the learning curve and procedure outcomes across surgeons with different experience levels. The study aims to minimize bias by including a broad patient population. The study involves surgeons using the anovo Surgical System, an endoscopic instrument control device designed to assist in controlling instrument arms during single site, natural orifice laparoscopic-assisted transvaginal benign gynecological surgeries. The study collects data on surgery times and adverse device events, while tracking surgeon competency development through the Skills Development Pathway. Participants will be patients undergoing gynecological surgery with the anovo Surgical System. Researchers will collect data on conversion rates to other surgical approaches and monitor for unanticipated adverse device effects up to 8 weeks post-surgery. Patients will also complete post-operative questionnaires to provide additional information. This observational registry study provides ongoing safety and performance data to understand device use in real-world settings.

CONDITIONS

Brief Title

Anovo™ Surgical System - Registry Study

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered participation
  • Patients must understand and sign the informed consent form, including data privacy authorization
  • Patients must be willing to complete a post-operative questionnaire
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Procedure duration

Participants undergo gynecological surgical procedures using the anovo™ Surgical System.

1 surgical procedure visit (in-person)

Post-operative Follow-up

Duration - 8 weeks

Participants are monitored for safety and effectiveness of the device after surgery, including completion of a post-operative questionnaire.

Visits during 8 weeks after surgery including post-operative questionnaire

Trial Site Locations

Total: 1 location

1

AdventHealth

Celebration, Florida, United States, 34747

Actively Recruiting

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Research Team

S

Sharon H Branch

M

Matthew McKittrick

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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