Anovo Surgical System in Ventral Hernia

NCT06457971 | Recruiting DMC

• 1 other identifier: MEMIC-12219
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• IntraOperative Procedural Outcomes - AE and SADE

  Intra-Operative

• IntraOperative Procedural Outcomes - Device/Procedure AE

  Intra-Operative

• IntraOperative Procedural Outcomes - Time

  Intra-Operative

• Post Operative Procedural Outcomes - AE and SADE

  Through study completion, an average of 4 weeks.

• Post Operative Procedural Outcomes - Wound Seroma

  Through study completion, an average of 4 weeks.

Study Arms (1)

Robotic Ventral Hernia

EXPERIMENTAL

Subjects undergoing robotic ventral hernia with the Anovo Surgical System.

Device: Robotic Ventral Hernia Repair

Interventions

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

Robotic Ventral Hernia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Momentis Surgical: lead

Study Sites (2)

Imelda Hospital

Bonheiden, Belgium

RECRUITING

Hadassah Medical Center

Jerusalem, Israel

COMPLETED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maya Lieb

CONTACT

+972-50-8852822; maya.lieb@momentissurgical.com

Michael Conditt, PhD

CONTACT

+0017132408675; michael.conditt@momentissurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 13, 2024
• Study Start: January 14, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); BE (1)