Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery

Обзор

Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery

Подробное описание

This trial adopts a prospective, multicenter, single-arm objective value design.For subjects scheduled to undergo thoracoabdominal endoscopic surgery system-assisted laparoscopic surgeries in the departments of urology, general surgery, gynecology and thoracic surgery, the thoracoabdominal endoscopic surgery system developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. will be used to perform remote laparoscopic surgeries in the above four departments, and the efficacy and safety of the investigational medical device in the treatment of remote laparoscopic surgeries in these four departments will be evaluated.

Вмешательства

• Устройство Robot-assisted surgery
  Surgery with the Cornerstone Surgical Robot.

Первичные конечные точки

• Surgical non-referral rate [Срок оценки: during the surgery]

Вторичные конечные точки (3)

• The surgeon's operating time [Срок оценки: during the surgery]
• Intraoperative blood loss [Срок оценки: during the surgery]
• Length of stay [Срок оценки: The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.]

Критерии участия

Критерии включения

• Age ≥ 18 and ≤ 80 years;
• Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).
• Subjects voluntarily participate in the clinical trial, and subjects or their guardians give informed consent and sign the informed consent form.
• Willing to cooperate with and complete trial follow-ups and relevant examinations.

Критерии исключения

• Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);
• With other malignancies or a previous history of other malignancies.
• Preoperative imaging suggests that the tumour has distant metastases.
• The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.
• Severe bleeding tendencies or coagulopathic disorders.
• With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
• Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
• Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Lai EC, Tang CN. Long-term Survival Analysis of Robotic Versus Conventional Laparoscopic Hepatectomy for Hepatocellular Carcinoma: A Comparative Study. Surg Laparosc Endosc Percutan Tech. 2016 Apr;26(2):162-6. doi: 10.1097/SLE.0000000000000254. PMID 27031650

Идентификаторы

NCT: NCT07382635 · F-00300-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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