Clinical trial NCT06457971: Anovo Surgical System in Ventral Hernia
Official title: Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Momentis Surgical
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Rate of Conversion
timeFrame: Intra-Operative
Secondary outcomes:
measure: IntraOperative Procedural Outcomes - AE and SADE
timeFrame: Intra-Operative
measure: IntraOperative Procedural Outcomes - Device/Procedure AE
timeFrame: Intra-Operative
measure: IntraOperative Procedural Outcomes - Time
timeFrame: Intra-Operative
measure: Post Operative Procedural Outcomes - AE and SADE
timeFrame: Through study completion, an average of 4 weeks.
measure: Post Operative Procedural Outcomes - Wound Seroma
timeFrame: Through study completion, an average of 4 weeks.
measure: Post Operative Procedural Outcomes - SSI
timeFrame: Through study completion, an average of 4 weeks.
measure: Post Operative Procedural Outcomes - Length of Stay
timeFrame: Through hospital discharge, up to approximately 3 days
measure: Procedure Completion
timeFrame: Intra-Operative
measure: Console Time
timeFrame: Intra-Operative
measure: Docking Time
timeFrame: Intra-Operative
measure: Draping Time
timeFrame: Intra-Operative
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References: