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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Ventral Hernia | Experimental | Subjects undergoing robotic ventral hernia with the Anovo Surgical System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Ventral Hernia Repair | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate 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. | Intra-Operative |
| Measure | Description | Time Frame |
|---|---|---|
| IntraOperative Procedural Outcomes - AE and SADE | IntraOperative Adverse and Serious Adverse Events | Intra-Operative |
| IntraOperative Procedural Outcomes - Device/Procedure AE | IntraOperative device related and / or procedure related Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Lieb | Contact | +972-50-8852822 | maya.lieb@momentissurgical.com | |
| Michael Conditt, PhD | Contact | +0017132408675 | michael.conditt@momentissurgical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Hospital | Recruiting | Bonheiden | Belgium |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Intra-Operative |
| IntraOperative Procedural Outcomes - Time | IntraOperative Operative Time | 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 | Through study completion, an average of 4 weeks. |
| Post Operative Procedural Outcomes - Wound Seroma | Post operative procedural outcomes such as post operative wound seroma | Through study completion, an average of 4 weeks. |
| Post Operative Procedural Outcomes - SSI | Post operative procedural outcomes such as surgical site infection | Through study completion, an average of 4 weeks. |
| Post Operative Procedural Outcomes - Length of Stay | Post operative procedural outcomes such as length of hospital stay | Through hospital discharge, up to approximately 3 days |
| Procedure Completion | Rate of procedure completion with the device | Intra-Operative |
| Console Time | Length of time the surgeon is actively using the surgeon console to control the robotic device | Intra-Operative |
| Docking Time | Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula. | Intra-Operative |
| Draping Time | Length of time spent draping the robotic device | Intra-Operative |
| Hadassah Medical Center | Completed | Jerusalem | Israel |