Ventral Hernia
Conditions
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.
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
Sponsors
Momentis Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| IntraOperative Procedural Outcomes - Device/Procedure AE | Intra-Operative | IntraOperative device related and / or procedure related Adverse Event |
| IntraOperative Procedural Outcomes - Time | Intra-Operative | IntraOperative Operative Time |
| 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 |
| Post Operative Procedural Outcomes - Wound Seroma | Through study completion, an average of 4 weeks. | Post operative procedural outcomes such as post operative wound seroma |
| Post Operative Procedural Outcomes - SSI | Through study completion, an average of 4 weeks. | Post operative procedural outcomes such as surgical site infection |
| IntraOperative Procedural Outcomes - AE and SADE | Intra-Operative | IntraOperative Adverse and Serious Adverse Events |
| Procedure Completion | Intra-Operative | Rate of procedure completion with the device |
| 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 - Length of Stay | Through hospital discharge, up to approximately 3 days | Post operative procedural outcomes such as length of hospital stay |
Countries
Belgium, Israel
Contacts
Primary ContactMaya Lieb
Backup ContactMichael Conditt, PhD
Outcome results
None listed