Идёт набор NCT06457971

Anovo Surgical System in Ventral Hernia

Без фазы С лечением Ventral Hernia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Robotic Ventral Hernia Repair.
Кому может быть актуально: Состояния в реестре: Ventral Hernia. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия, Израиль
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia

Обзор

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.

Вмешательства

Устройство 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

Первичные конечные точки

Rate of Conversion [Срок оценки: Intra-Operative]

Вторичные конечные точки (11)

IntraOperative Procedural Outcomes - AE and SADE [Срок оценки: Intra-Operative]
IntraOperative Procedural Outcomes - Device/Procedure AE [Срок оценки: Intra-Operative]
IntraOperative Procedural Outcomes - Time [Срок оценки: Intra-Operative]
Post Operative Procedural Outcomes - AE and SADE [Срок оценки: Through study completion, an average of 4 weeks.]
Post Operative Procedural Outcomes - Wound Seroma [Срок оценки: Through study completion, an average of 4 weeks.]
Post Operative Procedural Outcomes - SSI [Срок оценки: Through study completion, an average of 4 weeks.]
Post Operative Procedural Outcomes - Length of Stay [Срок оценки: Through hospital discharge, up to approximately 3 days]
Procedure Completion [Срок оценки: Intra-Operative]
Console Time [Срок оценки: Intra-Operative]
Docking Time [Срок оценки: Intra-Operative]
Draping Time [Срок оценки: Intra-Operative]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да