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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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
Imelda Hospital
Bonheiden, Belgium
RECRUITINGHadassah Medical Center
Jerusalem, Israel
COMPLETEDRate of Conversion
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.
Time frame: Intra-Operative
IntraOperative Procedural Outcomes - AE and SADE
IntraOperative Adverse and Serious Adverse Events
Time frame: Intra-Operative
IntraOperative Procedural Outcomes - Device/Procedure AE
IntraOperative device related and / or procedure related Adverse Event
Time frame: Intra-Operative
IntraOperative Procedural Outcomes - Time
IntraOperative Operative Time
Time frame: Intra-Operative
Post Operative Procedural Outcomes - AE and SADE
Post operative procedural outcomes such as Adverse and Serious Adverse Events and Series Adverse Device Effects
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - Wound Seroma
Post operative procedural outcomes such as post operative wound seroma
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - SSI
Post operative procedural outcomes such as surgical site infection
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - Length of Stay
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Post operative procedural outcomes such as length of hospital stay
Time frame: Through hospital discharge, up to approximately 3 days
Procedure Completion
Rate of procedure completion with the device
Time frame: Intra-Operative
Console Time
Length of time the surgeon is actively using the surgeon console to control the robotic device
Time frame: Intra-Operative
Docking Time
Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula.
Time frame: Intra-Operative
Draping Time
Length of time spent draping the robotic device
Time frame: Intra-Operative