Anovo™ Surgical System - Registry Study

Momentis Surgical

Status: Enrolling

Conditions: GYN Disorders

Treatments: Device: anovo™ Surgical System

Study type: Observational

Funder types: Industry

Identifiers

NCT05945433

Momentis2023GYNRegistry

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

300 participants in 1 patient group

Patients undergoing gynecological surgical procedure with the anovo Surgical System

Treatment:

Device: anovo™ Surgical System