Anovo Surgical System in Ventral Hernia (CLEVER)

Momentis Surgical

Status

Enrolling

Conditions

Ventral Hernia

Treatments

Device: Robotic Ventral Hernia Repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT06457971

MEMIC-12219

Details and patient eligibility

About

The study is aimed to clinically assess the AnovoTM Surgical System in ventral hernia procedures. Extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is at least 18 years old.
Subjects able to provide written informed consent.
Subject deemed eligible candidate by surgeon and will comply with the study procedures.
Subjects with ventral hernia.
Subjects with ASA grade I to III.
Subject must sign and date informed consent prior to treatment.
Subject can undergo general anesthesia per anesthesiologist assessment.

Exclusion criteria

Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation.
Subject has medical condition, which in the judgement of the investigator makes the subject a poor candidate for the investigational procedure.
Participation in another clinical trial that is in the active phase.
Subject unwilling or inability to follow procedures outlined in the protocol.
Subjects who are not suitable for robotic surgery, the Subject will be excluded from the study and the will be considered a screen failure and the surgeon will proceed with a standard multiport laparoscopic Hernia repair.
Subjects who present any adverse event before use the Anovo Surgical System ("Anovo") that can affect evaluation of safety and performance of Investigational Device.