What is the Anovo Surgical System studying for ventral hernia repair?

The Anovo Surgical System is being studied to assess its use in robotic ventral hernia repair. Researchers aim to evaluate how well the system performs during surgery and its safety. Momentis Surgical is leading this clinical trial to better understand this new surgical technology.

Who may be eligible for this ventral hernia clinical trial?

Adults aged 18 years or older with a diagnosis of ventral hernia may be eligible. Participants must be able to provide informed consent, have an ASA grade from I to III, and be suitable candidates for robotic surgery. Please review eligibility criteria for more details.

Is there any cost to participate in this ventral hernia clinical trial?

Study-related care, including the use of the surgical system and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

Healthy Volunteers

ID06457971

Study of the Anovo Surgical System for Robotic Ventral Hernia Repair in Adults

Led by Momentis Surgical · Updated on 2024-11-21

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to clinically evaluate the Anovo Surgical System in patients undergoing ventral hernia repair. The study focuses on assessing the safety and performance of this robotic system, which has undergone extensive preclinical testing to ensure its integrity. The system is designed to assist surgeons in accurately controlling robotic arms for tissue manipulation during laparoscopic surgery. Participants will undergo robotic ventral hernia repair using the Anovo Surgical System, which features articulated robotic arms to facilitate access and closure of the fascial defect. The procedure involves endoscopic control of instruments for tasks like grasping, dissection, and electrosurgery. This study includes monitoring both intra-operative and post-operative outcomes, including procedure times, adverse events, wound healing, and hospital stay. During the study, participants will be closely monitored with data collected on operative details such as conversion rates, procedure completion, console and docking times, and adverse events related to the device and procedure. Post-operative assessments will continue for about four weeks to evaluate complications like wound seroma and surgical site infections. The study allows for comprehensive safety and procedural outcome tracking up to hospital discharge and throughout the follow-up period.

CONDITIONS

Brief Title

Anovo Surgical System in Ventral Hernia

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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 will not qualify if you...

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 makes them a poor candidate for the investigational procedure.
Participation in another clinical trial that is in the active phase.
Subject unwilling or unable to follow procedures outlined in the protocol.
Subjects not suitable for robotic surgery will be excluded and treated with standard laparoscopic repair.
Subjects with adverse events before using the Anovo Surgical System that affect safety or performance evaluation.

Research Team

Maya Lieb

Michael Conditt, PhD

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