Using the Anovo Surgical System for ventral hernia repair
Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia
This study is testing a new robotic system for repairing ventral hernias to see if it is safe and effective for adults who need this surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Momentis Surgical Industry-sponsored |
| Locations | 2 sites (Bonheiden and 1 other locations) |
| Trial ID | NCT06457971 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the Anovo Surgical System's effectiveness and safety in performing robotic ventral hernia repairs. Participants will undergo the procedure after extensive preclinical testing has confirmed the system's integrity. Eligible candidates include adults with ventral hernias who meet specific health criteria and can provide informed consent. The study aims to gather clinical data to support the system's use in surgical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with ventral hernias who are suitable for robotic surgery.
Not a fit: Patients who are pregnant, breastfeeding, or have medical conditions that disqualify them from robotic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved surgical outcomes and recovery for patients with ventral hernias.
How similar studies have performed: Other studies have shown promise in robotic surgical approaches for hernia repair, suggesting potential for success with this novel system.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bonheiden and 1 other locations
- Imelda Hospital — Bonheiden, Belgium (Recruiting)
- Hadassah Medical Center — Jerusalem, Israel (Completed)
Study contacts
- Study coordinator: Maya Lieb
- Email: maya.lieb@momentissurgical.com
- Phone: +972-50-8852822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.