Prostate Cancer
Conditions
Keywords
High-Intensity Focused Ultrasound (HIFU), Telesurgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHigh-Intensity Focused Ultrasound (HIFU) robotic device
Participants will receive surgery using the High-Intensity Focused Ultrasound (HIFU) robotic device, using the existing, secured network as part of the Cleveland Clinic infrastructure, to deliver focal ablative treatment for prostate cancer.
Sponsors
Case Comprehensive Cancer Center
Focal One, INC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time (minutes) | Day 1 (up to 90 days) | Total operative time will be measured in minutes on the day of surgery. |
| Total robotic console time (minutes) | Day 1 (up to 90 days) | Total robotic console time is the amount of time that the robotic console is in use during surgery and will be measured in minutes on the day of surgery. |
| Distance between the two institutions (miles) | Day 1 (up to 90 days) | The distance between two institutions refers to the distance between the surgeon console operated by the remote surgeon and the robotic patient cart where the patient is located. If these are at two different institutions, distance between institutions will be measured in miles. |
| Round-trip latency time (milliseconds) | Day 1 (up to 90 days) | Round-trip latency time is defined as the total time delay between an action initiation on the robotic console and that corresponding action being carried out. Round-trip latency time is measured in milliseconds (ms). |
| Intraoperative blood loss (milliliters (mL)) | Day 1 (up to 90 days) | Intraoperative blood loss will be measured in milliliters (mL) on the day of surgery. |
| Conversion from remote to in-house surgeon | Day 1 (up to 90 days) | Conversion from remote to in-house surgeon occurs when the network latency exceeds 300 milliseconds (ms). This will be measured as number of instances of conversion. |
| Conversion from planned surgery to other techniques | Day 1 (up to 90 days) | Conversion will be measured as number of instances of conversion from planned surgery to other techniques, at the discretion of the surgeon. |
| Conversion from one robotic surgical system to another | Day 1 (up to 90 days) | Conversion will be measured as number of instances of conversion from the planned robotic surgical system to other backup surgical systems, at the discretion of the surgeon. |
| Intraoperative complications | Day 1 (up to 90 days) | Intraoperative complications will be measured as the number of instances of complications. |
| Evidence of intraoperative network interruptions | Day 1 (up to 90 days) | Intraoperative network interruptions include those pertaining to the robotic procedure, including interruptions to the audiovisual feed, and this will be measured as number of instances of interruptions. |
| Evidence of intraoperative device malfunctions | Day 1 (up to 90 days) | This will be measured as the number of instances of device malfunctions during surgery. |
| Postoperative hospital length of stay (hours) | Up to Day 90 | Postoperative hospital length of stay will be measured in hours. |
| Postoperative complications | Up to Day 90 | Postoperative complications will be measured as the number of instances of complications. |
| Hospital readmission within 90 days of surgery | Up to Day 90 | Hospital readmissions will be measured as number of instances of readmissions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRuben Olivares, MD
Case Comprehensive Cancer Center, Cleveland Clinic
Outcome results
None listed