Anovo Surgical System in Ventral Hernia

NCT ID: NCT06457971

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-14

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventral Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robotic Ventral Hernia

Subjects undergoing robotic ventral hernia with the Anovo Surgical System.

Group Type EXPERIMENTAL

Robotic Ventral Hernia Repair

Intervention Type DEVICE

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Momentis Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Imelda Hospital

Bonheiden, , Belgium

Site Status RECRUITING

Hadassah Medical Center

Jerusalem, , Israel

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

Belgium Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maya Lieb

Role: CONTACT

+972-50-8852822

Michael Conditt, PhD

Role: CONTACT

+0017132408675

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jenny Duerinckx

Role: primary

32476269668

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MEMIC-12219

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hernia Repair in Multiply Morbid Patients
NCT00930787 TERMINATED PHASE4