Anovo Surgical System in Ventral Hernia
- Conditions
- Ventral Hernia
- Interventions
- Device: Robotic Ventral Hernia Repair
- Registration Number
- NCT06457971
- Lead Sponsor
- Momentis Surgical
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Robotic Ventral Hernia Robotic Ventral Hernia Repair Subjects undergoing robotic ventral hernia with the Anovo Surgical System.
- Primary Outcome Measures
Name Time Method Rate of Conversion Intra-Operative The primary endpoint is rate of conversion to open surgery or multiport laparoscopic approach. As this is a clinical assessment, no pre-determined success criteria have been set.
- Secondary Outcome Measures
Name Time Method IntraOperative Procedural Outcomes - Time Intra-Operative IntraOperative Operative Time
Console Time Intra-Operative Length of time the surgeon is actively using the surgeon console to control the robotic device
Docking Time Intra-Operative Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula.
Draping Time Intra-Operative Length of time spent draping the robotic device
Post Operative Procedural Outcomes - AE and SADE Through study completion, an average of 4 weeks. Post operative procedural outcomes such as Adverse and Serious Adverse Events and Series Adverse Device Effects
Procedure Completion Intra-Operative Rate of procedure completion with the device
IntraOperative Procedural Outcomes - AE and SADE Intra-Operative IntraOperative Adverse and Serious Adverse Events
Post Operative Procedural Outcomes - SSI Through study completion, an average of 4 weeks. Post operative procedural outcomes such as surgical site infection
Post Operative Procedural Outcomes - Length of Stay Through hospital discharge, up to approximately 3 days Post operative procedural outcomes such as length of hospital stay
IntraOperative Procedural Outcomes - Device/Procedure AE Intra-Operative IntraOperative device related and / or procedure related Adverse Event
Post Operative Procedural Outcomes - Wound Seroma Through study completion, an average of 4 weeks. Post operative procedural outcomes such as post operative wound seroma
Trial Locations
- Locations (2)
Imelda Hospital
🇧🇪Bonheiden, Belgium
Hadassah Medical Center
🇮🇱Jerusalem, Israel