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NCT Number: NCT06457971

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imelda Hospital, Bonheiden, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Rate of Conversion

    Time frame: Intra-Operative

    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.

Secondary outcomes

  1. IntraOperative Procedural Outcomes - AE and SADE

    Time frame: Intra-Operative

    IntraOperative Adverse and Serious Adverse Events

  2. IntraOperative Procedural Outcomes - Device/Procedure AE

    Time frame: Intra-Operative

    IntraOperative device related and / or procedure related Adverse Event

  3. IntraOperative Procedural Outcomes - Time

    Time frame: Intra-Operative

    IntraOperative Operative Time

  4. Post Operative Procedural Outcomes - AE and SADE

    Time frame: Through study completion, an average of 4 weeks.

    Post operative procedural outcomes such as Adverse and Serious Adverse Events and Series Adverse Device Effects

  5. Post Operative Procedural Outcomes - Wound Seroma

    Time frame: Through study completion, an average of 4 weeks.

    Post operative procedural outcomes such as post operative wound seroma

  6. Post Operative Procedural Outcomes - SSI

    Time frame: Through study completion, an average of 4 weeks.

    Post operative procedural outcomes such as surgical site infection

  7. Post Operative Procedural Outcomes - Length of Stay

    Time frame: Through hospital discharge, up to approximately 3 days

    Post operative procedural outcomes such as length of hospital stay

  8. Procedure Completion

    Time frame: Intra-Operative

    Rate of procedure completion with the device

  9. Console Time

    Time frame: Intra-Operative

    Length of time the surgeon is actively using the surgeon console to control the robotic device

  10. Docking Time

    Time frame: Intra-Operative

    Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula.

  11. Draping Time

    Time frame: Intra-Operative

    Length of time spent draping the robotic device

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Lieb

CONTACT

[email protected]

+972-50-8852822

Michael Conditt, PhD

CONTACT

[email protected]

+0017132408675

Sponsors and collaborators

Lead sponsor

Momentis Surgical

Industry

Registry information

Official study title

Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia

Acronym: CLEVER

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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