Anovo Surgical System in Ventral Hernia

Last updated: November 19, 2024
Sponsor: Momentis Surgical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pentalogy Of Cantrell

Hernia

Treatment

Robotic Ventral Hernia Repair

Clinical Study ID

NCT06457971
MEMIC-12219
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 studyprocedures.

  • 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

Exclusion Criteria:

  • Women who are pregnant or breast-feeding or who wish to become pregnant during theperiod of the clinical investigation.

  • Subject has medical condition, which in the judgement of the investigator makes thesubject 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 fromthe study and the will be considered a screen failure and the surgeon will proceedwith 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 InvestigationalDevice.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Robotic Ventral Hernia Repair
Phase:
Study Start date:
January 14, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Imelda Hospital

    Bonheiden,
    Belgium

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem,
    Israel

    Completed

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