Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-01-14
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robotic Ventral Hernia
Subjects undergoing robotic ventral hernia with the Anovo Surgical System.
Robotic Ventral Hernia Repair
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
Interventions
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Robotic Ventral Hernia Repair
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Momentis Surgical
INDUSTRY
Responsible Party
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Locations
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Imelda Hospital
Bonheiden, , Belgium
Hadassah Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MEMIC-12219
Identifier Type: -
Identifier Source: org_study_id
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