Anovo Surgical System in Ventral Hernia

Ventral Hernia Clinical Trial

— CLEVER  

Official title:

Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06457971
• Other study ID #: MEMIC-12219
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2024
• Est. completion date: June 23, 2024

Study information

• Verified date: June 2024
• Source: Momentis Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 23, 2024
• Est. primary completion date: May 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Robotic Ventral Hernia Repair
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

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Momentis Surgical

Countries where clinical trial is conducted

Belgium,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	IntraOperative Procedural Outcomes - AE and SADE	IntraOperative Adverse and Serious Adverse Events	Intra-Operative
Secondary	IntraOperative Procedural Outcomes - Device/Procedure AE	IntraOperative device related and / or procedure related Adverse Event	Intra-Operative
Secondary	IntraOperative Procedural Outcomes - Time	IntraOperative Operative Time	Intra-Operative
Secondary	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.
Secondary	Post Operative Procedural Outcomes - Wound Seroma	Post operative procedural outcomes such as post operative wound seroma	Through study completion, an average of 4 weeks.
Secondary	Post Operative Procedural Outcomes - SSI	Post operative procedural outcomes such as surgical site infection	Through study completion, an average of 4 weeks.
Secondary	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
Secondary	Procedure Completion	Rate of procedure completion with the device	Intra-Operative
Secondary	Console Time	Length of time the surgeon is actively using the surgeon console to control the robotic device	Intra-Operative
Secondary	Docking Time	Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula.	Intra-Operative
Secondary	Draping Time	Length of time spent draping the robotic device	Intra-Operative