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Anovo™ Surgical System - Registry Study

Recruiting
years of age
Female
Phase N/A

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Overview

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.

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

Study details

GYN Disorders

NCT05945433

Momentis Surgical

27 January 2024

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