Anovo Surgical System in Ventral Hernia
Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia
Momentis Surgical
50 participants
Jan 14, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The AnovoTM Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS with graspers and electrosurgery devices for endoscopic manipulation of tissue including grasping, blunt dissection, approximation, and electrosurgery, during single site, laparoscopic surgical procedures. The AnovoTM System's articulated robotic arms allow the surgeon to access and reach different structures in the pelvic and abdominal cavity. Closing the fascial defect robotically is easier from a technical standpoint than attempting it with classical laparoscopic instruments
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06457971