Recruiting NCT06457971
Anovo Surgical System in Ventral Hernia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic Ventral Hernia Repair.
- Who it may be relevant to
- Registry conditions: Ventral Hernia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia
Overview
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.
Interventions
- 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
Primary outcome measures
- Rate of Conversion [Time frame: Intra-Operative]
Secondary outcome measures (11)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Imelda Hospital — Bonheiden
Israel · 1 center
- Hadassah Medical Center — Jerusalem
Identifiers
NCT: NCT06457971 · MEMIC-12219