Actively Recruiting
Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia Repair
Led by Momentis Surgical · Updated on 2024-11-21
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
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
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.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 3 days
Participants undergo robotic ventral hernia repair using the Anovo Surgical System followed by immediate post-operative care during hospital stay.
1 surgical procedure and hospital stay
Duration - Approximately 4 weeks
Participants are monitored for post-operative outcomes including adverse events, wound healing, and surgical site infections.
Follow-up visits during the 4 weeks after surgery
Trial Site Locations
Total: 2 locations
1
Imelda Hospital
Bonheiden, Belgium
Actively Recruiting
2
Hadassah Medical Center
Jerusalem, Israel
Completed
Research Team
M
Maya Lieb
M
Michael Conditt, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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