Health TrialsbyHealthPanel

Anovo Surgical System in Ventral Hernia

ConditionVentral Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMomentis Surgical

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Robotic Ventral HerniaExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Intra-Operative

Secondary outcomes

1

IntraOperative Procedural Outcomes - AE and SADE

IntraOperative Adverse and Serious Adverse Events

Time frame
Intra-Operative
2

IntraOperative Procedural Outcomes - Device/Procedure AE

IntraOperative device related and / or procedure related Adverse Event

Time frame
Intra-Operative
3

IntraOperative Procedural Outcomes - Time

IntraOperative Operative Time

Time frame
Intra-Operative
4

Post Operative Procedural Outcomes - AE and SADE

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Momentis Surgical

Lead sponsor

Source ClinicalTrials.gov
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