Ventral HerniaCLEVERNCT06457971
Anovo Surgical System in Ventral Hernia
A study testing Robotic Ventral Hernia Repair in people with Ventral Hernia, run by Momentis Surgical at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Robotic Ventral Hernia Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Imelda Hospital
Bonheiden
Jenny Duerinckx, 32476269668, jenny.duerinckx@imelda.be
Tim Tollens, MD
About this study
Official title: Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia
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
- Ventral Hernia
- Being tested
- Robotic Ventral Hernia Repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Ventral Hernia RepairDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Robotic Ventral Hernia | Experimental | Subjects undergoing robotic ventral hernia with the Anovo Surgical System. Receives: Device: Robotic Ventral Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-Operative
Secondary outcomes (11)
IntraOperative Procedural Outcomes - AE and SADE
IntraOperative Adverse and Serious Adverse Events
Measured: Intra-Operative
IntraOperative Procedural Outcomes - Device/Procedure AE
IntraOperative device related and / or procedure related Adverse Event
Measured: Intra-Operative
IntraOperative Procedural Outcomes - Time
IntraOperative Operative Time
Measured: 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
Measured: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - Wound Seroma
Post operative procedural outcomes such as post operative wound seroma
Measured: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - SSI
Post operative procedural outcomes such as surgical site infection
Measured: 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
Measured: Through hospital discharge, up to approximately 3 days
Procedure Completion
Rate of procedure completion with the device
Measured: Intra-Operative
Console Time
Length of time the surgeon is actively using the surgeon console to control the robotic device
Measured: Intra-Operative
Docking Time
Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula.
Measured: Intra-Operative
Draping Time
Length of time spent draping the robotic device
Measured: Intra-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start14 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Momentis Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457971
- Sponsor's protocol ID
- MEMIC-12219
- Acronym
- CLEVER
- Status last verified
- Nov 2024
- First submitted
- 30 May 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia
- ClinicalTrials.gov ID
- NCT06457971
- Acronym / sponsor ID
- CLEVER / MEMIC-12219
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Momentis SurgicalIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Ventral Hernia | Experimental | Device: Robotic Ventral Hernia RepairSubjects undergoing robotic ventral hernia with the Anovo Surgical System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Ventral Hernia RepairThe 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 | Device | Robotic Ventral Hernia |
Primary outcome
Rate of Conversion
Time frame: Intra-Operative
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.
11 secondary outcomes
IntraOperative Procedural Outcomes - AE and SADE
Time frame: Intra-Operative
IntraOperative Procedural Outcomes - Device/Procedure AE
Time frame: Intra-Operative
IntraOperative Procedural Outcomes - Time
Time frame: Intra-Operative
Post Operative Procedural Outcomes - AE and SADE
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - Wound Seroma
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - SSI
Time frame: Through study completion, an average of 4 weeks.
Post Operative Procedural Outcomes - Length of Stay
Time frame: Through hospital discharge, up to approximately 3 days
Procedure Completion
Time frame: Intra-Operative
Console Time
Time frame: Intra-Operative
Docking Time
Time frame: Intra-Operative
Draping Time
Time frame: Intra-Operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Ventral Hernia Repair in people with Ventral Hernia, run by Momentis Surgical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Lieb (+972-50-8852822, maya.lieb@momentissurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Conversion (time frame: Intra-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.