Actively Recruiting
Anovo Surgical System in Ventral Hernia
Led by Momentis Surgical · Updated on 2024-11-21
50
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 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.
AI-Screening
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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
CONTACT
M
Michael Conditt, PhD
CONTACT
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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