Anovo Surgical System in Ventral Hernia

Launched by MOMENTIS SURGICAL · Jun 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Anovo Surgical System to treat ventral hernias, which are bulges that can occur in the abdominal area. The goal is to see how well this system works and to ensure it is safe for patients. The trial is currently recruiting participants aged 18 and older, and those who are in good health (ASA grade I to III), which means they are generally fit for surgery. Participants must be able to provide consent and be suitable candidates for robotic surgery.

If you decide to join the trial, you will receive treatment using the Anovo Surgical System. Before starting, you’ll need to go through some assessments to ensure you meet the eligibility criteria. It’s important to know that certain individuals, like pregnant or breastfeeding women, or those with other medical conditions that might complicate the surgery, will not be eligible to participate. Overall, this trial aims to provide valuable information about a new approach to hernia repair that could benefit many patients in the future.

Gender

ALL

Eligibility criteria

• 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.