First Appendectomy Using Revolve Surgical Robotic Arm

Обзор

This study is testing a new surgical device called the Revolve Surgical System (RSS) during appendix removal surgery. The RSS is designed to help surgeons perform minimally invasive surgery with improved precision and stability while working at the patient's bedside, similar to standard laparoscopic surgery but with robotic assistance. This will be the first time the device is used in patients. It will be evaluated in three adults with uncomplicated appendicitis who are already scheduled to have an appendectomy. The purpose of the study is to assess whether the device can be used safely and effectively and to better understand how it performs during surgery.

Подробное описание

This study is testing a new Canadian surgical device called the Revolve Surgical System (RSS) during minimally invasive appendix removal surgery (appendectomy). The RSS is a small robotic support arm that helps the surgeon hold and control the camera and surgical instruments more steadily. It is designed to reduce hand tremor, improve precision, and decrease the need for extra assistants, while allowing the surgeon to remain beside the patient rather than operating from a remote console.

This will be the first time the RSS is used in human patients. Because of this, the main goal of the study is to make sure the device can be used safely and effectively during a routine operation. The study will include three adult patients with uncomplicated appendicitis who are already scheduled for a standard laparoscopic appendectomy.

The study will be done in a gradual, step-by-step way. In the first patient, the RSS will only hold the camera. In the second, it will hold the camera and one instrument. In the third, it will hold the camera and two instruments. This careful approach allows the surgical team to evaluate safety before increasing how much the device is used.

All other aspects of care will be the same as standard treatment. Patients will receive routine anesthesia, monitoring, and post-operative care. If the device does not function as expected at any time, it can be quickly removed, and the surgeon will immediately continue the operation using standard laparoscopic or open surgical techniques. Backup equipment will always be ready.

Researchers will record information such as setup time, length of surgery, any need to switch back to standard methods, and whether any device issues occur. Usual recovery information and any complications will also be tracked. Surgeons and patients may be asked to complete short feedback questionnaires.

There may be no direct benefit to participants, but the study could help improve future surgical care by making advanced minimally invasive technology more accessible and efficient. Findings from this pilot study will guide decisions about larger future studies.

Вмешательства

• Устройство Revolve Surgical System - RSS
  Participants in this single study arm will undergo a standard laparoscopic appendectomy with the assistance of the investigational Revolve Surgical System (RSS). The RSS is a bedside robotic support device designed to stabilize and position the laparoscopic camera and surgical instruments under the direct control of the operating surgeon. The intervention involves using the RSS to hold and guide selected instruments during surgery in a stepwise manner. In the first case, the device will support

Первичные конечные точки

• Successful Completion of Appendectomy Using RSS Without Conversion [Срок оценки: Intraoperative (from skin incision to completion of surgery)]

Вторичные конечные точки (1)

• System Usability Scale (SUS) Score [Срок оценки: Immediately post-procedure (same operative day)]

Критерии участия

Критерии включения

• Inpatients at Unity Health Toronto - St. Michael's Hospital scheduled for an elective appendectomy
• Ages of 21-40 years old
• Male and non-pregnant female patients (pregnancy test required)
• No co-morbidities
• Body Mass Index (BMI) between 18.5 and 25kg/m2
• On no medications
• Not taking any recreational drugs
• Uncomplicated acute appendicitis (confirmed through abdominal ultrasound or abdominal computed tomography (CT) scan)
• The pre-operative white blood cell count (WBC) must be between 4,500 - 15,000 cells per microliter.

Критерии исключения

• Any patient who does not have all the inclusion criteria described above.
• Imaging of perforated appendix, free air, phlegmon, abscess, fluid collection, other any abdominal disease.
• Any other abnormal laboratory test performed pre-operatively will cause the exclusion of the patient from the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07455487 · 25-235

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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