Anovo Surgical System in Ventral Hernia (CLEVER)

Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia

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 Overview

• Status: Recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Robotic Ventral Hernia Repair

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Lieb; Phone Number: +972-50-8852822; Email: maya.lieb@momentissurgical.com
• Study Contact Backup: Name: Michael Conditt, PhD; Phone Number: +0017132408675; Email: michael.conditt@momentissurgical.com

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imelda Hospital
    • Contact: Jenny Duerinckx; Phone Number: 32476269668; Email: jenny.duerinckx@imelda.be
    • Principal Investigator: Tim Tollens, MD
• Israel
  • Jerusalem, Israel
    • Completed
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Robotic Ventral Hernia; Subjects undergoing robotic ventral hernia with the Anovo Surgical System.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Momentis Surgical

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: MEMIC-12219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No