Anovo™ Surgical System - Registry Study

ConditionGYN Disorders

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorMomentis Surgical

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

anovo™ Surgical System
Device
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.

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Patients undergoing gynecological surgical procedure with the anovo Surgical System1 intervention

Trial outcomes

Primary outcomes

Conversion rate to open or laparoscopic approach

Time frame

Procedure

Rate of Unanticipated Adverse Device Effect

Time frame

8 Weeks Follow Up

Secondary outcomes

Surgery time (minutes)

Time frame

Procedure

Other outcomes

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)

Time frame

Procedure

Surgeon Safety Curve (cumulative UADEs against number of operations performed)

Time frame

Procedure

User Skills Development Survey

Time frame

Procedure