An interventional study of Robotic Ventral Hernia Repair in Ventral Hernia, sponsored by Momentis Surgical. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Momentis Surgical · Not applicable, Interventional, and Treatment
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Momentis Surgical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects undergoing robotic ventral hernia with the Anovo Surgical System.
Device: 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
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
IntraOperative Procedural Outcomes - AE and SADE
IntraOperative Adverse and Serious Adverse Events
Time frame: Intra-Operative
IntraOperative Procedural Outcomes - Device/Procedure AE
IntraOperative device related and / or procedure related Adverse Event
Time frame: Intra-Operative
IntraOperative Procedural Outcomes - Time
IntraOperative Operative Time
Time frame: Intra-Operative
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.
Post Operative Procedural Outcomes - Wound Seroma
Post operative procedural outcomes such as post operative wound seroma
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - SSI
Post operative procedural outcomes such as surgical site infection
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - Length of Stay
Post operative procedural outcomes such as length of hospital stay
Time frame: Through hospital discharge, up to approximately 3 days
Procedure Completion
Rate of procedure completion with the device
Time frame: Intra-Operative
Console Time
Length of time the surgeon is actively using the surgeon console to control the robotic device
Time frame: Intra-Operative
Docking Time
Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula.
Time frame: Intra-Operative
Draping Time
Length of time spent draping the robotic device
Time frame: Intra-Operative
Not enrolling at this site.
Plan to share: No
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