Maestro 1.1 Post-Market Registry

Обзор

The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.

Вмешательства

• Устройство Laparoscopic surgery using the Maestro Platform
  Patients scheduled for laparoscopic surgery will be operated on as per standard of care, using standard port, surgical table and instrument placements (following local applicable guidelines), and off-the-shelf surgical equipment. Standard of care surgical technique following local applicable guidelines will be used. The Maestro Platform may be used to position and hold the scope as well as the retractor in the locations determined by the surgeon during the procedure, with the ability to revert

Первичные конечные точки

• Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications [Срок оценки: Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications [ Time Frame: 30 days ]]
• Completion of the procedure using the Maestro Platform without conversion to a manual minimally invasive or open surgical procedure specifically due to a device failure or malfunction [Срок оценки: During procedure]

Вторичные конечные точки (12)

• Incidence of procedure-specific complications [Срок оценки: During procedure]
• Procedure duration [Срок оценки: During procedure]
• Wheels-in Wheels-out [Срок оценки: During procedure]
• Skin to Skin time [Срок оценки: During procedure]
• Recovery time [Срок оценки: 30 days]
• Turnaround time [Срок оценки: During Procedure]
• Camera cleaning rate [Срок оценки: During procedure]
• Post operative pain [Срок оценки: 1 day after the procedure]
• Potential post-operative complications [Срок оценки: 30 days]
• Human resource utilization for surgical assistance in the operating room [Срок оценки: During procedure]
• Surgeon comfort evaluated on 1-5 scale at the end of the procedure [Срок оценки: During procedure]
• Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure [Срок оценки: During procedure]

Критерии участия

Критерии включения

• Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.

Критерии исключения

• Participants might be excluded based on the investigator's discretion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 6 центров

• Rose Medical Center — Denver
• Lee Health — Fort Myers
• Baptist Health — Jacksonville
• Baptist Medical Center Beaches — Jacksonville
• Orlando Veterans Affairs Medical Center — Orlando
• Surgeon's Point ASC — Cedar Park

Франция · 5 центров

• Hôpital Privé Arnault Tzanck — Mougin
• Polyclinique de Franche-Comté — Besançon
• Clinique Bouchard — Marseille
• Institut Arnault Tzanck — Saint-Laurent-du-Var
• Clinique de l'Orangerie — Strasbourg

Бельгия · 1 центр

• Chirec Delta — Auderghem

Идентификаторы

NCT: NCT06103136 · Maestro1.1 PostMarket Registry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗