Robotic Telesurgery for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Surgical success rate
研究概览
简要总结
The goal of this clinical trial is to confirm the safety and feasibility of robotic telesurgery when used for the surgical management of prostate cancer in participates undergoing treatment for prostate cancer. In this clinical trial, participants will receive robotic telesurgery treatment for prostate cancer.
详细描述
Robotic surgery began in the early 2000s and has been increasingly considered the preferred surgical approach for various urological surgeries. Urologists were among the first doctors to adopt this technology, and today, robotic surgery is included in many medical guidelines as a main treatment option for localized urological cancers. As robotic systems become more widely available and continue to improve, many new treatment options have been developed in the field of urologic cancer care. These advances offer the benefit of less invasive surgery. However, having more complex surgical options can also create challenges. Access to highly trained surgeons and specialized treatments may be limited to large academic or major medical centers, making it harder for some people to receive this care.
Telesurgery has been introduced as a way to make the process of robotic surgical care more accessible. Telesurgery is defined as the completion of a robotic surgical procedure by a remote surgeon that is located distant to the person receiving surgery. Although telesurgery was first described by researchers in 2001, the widespread adoption of telesurgery is limited by the availability of surgical technology, reliable and secure high-speed network infrastructure, and regulatory constraints.
In addition to the robotic console and participant cart required for the standard robotic procedures, telesurgery also requires an additional robotic console for the remote surgeon that mimics the functionality of the primary console. In addition, separate network tests using phantom models constituted mandatory preparation prior to the actual procedure to ensure a reliable, low-latency network infrastructure.
Preliminary studies have reported on the safety of robotic telesurgery. Most of these studies involve using telesurgery for the management of localized prostate cancer. However, these studies are limited by small sample sizes, heterogeneous study design, robotic surgical platform, and clinical practices. Furthermore, there remains a lack of consensus on best practice guidelines on robotic telesurgery, particularly involving the network requirements, ethical considerations, and intraoperative requirements.
This study aims to confirm the safety and feasibility of robotic telesurgery when used for the surgical management of prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult participants, aged 18 years or older
- •Participant has been indicated for a focal therapy treatment for prostate cancer, radical prostatectomy, or partial nephrectomy robotic procedures
- •Each participant should fit the clinical criteria to undergo robotic radical procedure, using either the Single Port or Multi Port robotic approaches, laparoscopic, or an open surgical procedure
- •Each participant should be willing to participate and consent to participate, as documented by a signed informed consent form
排除标准
- •Participants for which minimally invasive surgery is contraindicated as determined by the investigator
- •Participants with comorbidities or medical characteristics, which would preclude the surgical procedure or the equivalent alternative in the opinion of the investigator
- •Participants who have been diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard of care
- •Non-oncology participants with an estimated life expectancy of less than 6 months
- •Female participants pregnant at the time of the surgical procedure
- •Participants who are considered to be part of a vulnerable population, including but not limited to those without sufficient mental capacity
- •Participants who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- •Participants with active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
研究组 & 干预措施
Robotic telesurgery
干预措施: High-Intensity Focused Ultrasound (HIFU) robotic device (Procedure)
结局指标
主要结局
Surgical success rate
时间窗: Day 1 (up to 90 days)
Surgical success rate is defined as the procedure not requiring any conversion, without any evidence of perioperative complications. Conversion was defined as the switch from the intended surgery to other surgical techniques and/or modalities. Surgical complications of interest included major complications defined as those scoring grades 3a and above according to the Clavien-Dindo classification systems.
次要结局
- Intraoperative blood loss (milliliters (mL))(Day 1 (up to 90 days))
- Postoperative complications(Up to Day 90)
- Hospital readmission within 90 days of surgery(Up to Day 90)
- Total operative time (minutes)(Day 1 (up to 90 days))
- Total robotic console time (minutes)(Day 1 (up to 90 days))
- Distance between the two institutions (miles)(Day 1 (up to 90 days))
- Round-trip latency time (milliseconds)(Day 1 (up to 90 days))
- Conversion from remote to in-house surgeon(Day 1 (up to 90 days))
- Conversion from planned surgery to other techniques(Day 1 (up to 90 days))
- Conversion from one robotic surgical system to another(Day 1 (up to 90 days))
- Intraoperative complications(Day 1 (up to 90 days))
- Evidence of intraoperative network interruptions(Day 1 (up to 90 days))
- Evidence of intraoperative device malfunctions(Day 1 (up to 90 days))
- Postoperative hospital length of stay (hours)(Up to Day 90)