Exploring the Potential of Robotic Telesurgery in Remote Settings

Официальное название

Advancing Humanitarian Healthcare: Exploring the Potential of Robotic Telesurgery in Remote Settings - A Multicentric Prospective Study

Обзор

This study involves a type of robotic surgery called telesurgery, where a highly trained surgeon performs the surgical procedure using a secure internet connection to operate on a patient in a different location. Urologists from The goal of this study is to find out how safe and effective telesurgery is when used in real hospitals. The study aims to understand how well Telesurgery works in different settings, what technical challenges might come up (like internet speed or delays), and how it can be used to train new surgeons.

Вмешательства

• Устройство Telesurgery utilizing Microport Medbot Robotic Platform
  A robotic surgery for prostate disease via telesurgery, where a highly trained surgeon performs the operation remotely using a secure internet connection.

Первичные конечные точки

• Primary Outcome Measures (Endpoints) [Срок оценки: The measured time frame for this outcome will be measured by the investigator and tech team from the start of the surgical procedure through the stop time of the surgical procedure. Approximately 90 minutes in length.]
• Secondary Endpoints [Срок оценки: This will be measured by the investigator from the start of the surgical procedure through the completion of the surgical procedure.]
• Safety and Feasibility: Maintenance of stable connection [Срок оценки: The measured time frame for this outcome will be measured by the investigator and tech team from the start of the surgical procedure through the stop time of the surgical procedure. Approximately 90 minutes in length.]

Критерии участия

Критерии включения

• Age 18 - 90
• Male or female
• Eligible participants for this telesurgery study must have a clearly defined indication for robotic urologic surgery, specifically:

• Localized Prostate Cancer (ICD-10: C61), appropriate for robotic radical prostatectomy.

OR

-Benign Prostate diseases appropriate for robotic simple prostatectomy (ICD-10: N40) These diagnoses are confirmed by clinical examination, imaging, and/or pathology prior to surgical planning. Patients with vague or unspecified urologic conditions will be excluded to ensure the safety and appropriateness of the surgical intervention.

• Primary diagnosis of urinary system disease and prostate disorders (C61 and N40.1) scheduled to undergo treatment with robotic surgery. These patients don't have access to robotic surgery in their routine and the study will give them the opportunity to have advanced technology and the gold-standard treatment with experts in the field.
• Willing to participate in the study
• Mentally capable of comprehending the study protocol

Критерии исключения

• Patients who, based on multidisciplinary evaluation (surgical, anesthetic, and medical), are deemed not suitable for robotic surgery due to high perioperative risk. This includes but is not limited to:

• Uncontrolled cardiovascular, pulmonary, or metabolic disease.
• Severe anesthetic risk classified as ASA Class IV or higher.
• Patients enrolled in another interventional research study that may interfere with surgical safety or outcomes.
• Patients unwilling or unable to comply with the perioperative and follow-up schedule.
• Vulnerable populations are excluded from this study, including:

• Minors (under 18 years old)
• Prisoners
• Cognitively impaired or decisional incapacitated individuals

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

Оценка устройства

Центры проведения

США · 1 центр

• AdventHealth — Celebration

Публикации

• Rocco B, Moschovas MC, Saikali S, Gaia G, Patel V, Sighinolfi MC. Insights from telesurgery expert conference on recent clinical experience and current status of remote surgery. J Robot Surg. 2024 Jun 4;18(1):240. doi: 10.1007/s11701-024-01984-w. PMID 38833111
• Reddy SK, Saikali S, Gamal A, Moschovas MC, Rogers T, Dohler M, Marescaux J, Patel V. Telesurgery: A Systematic Literature Review and Future Directions. Ann Surg. 2025 Aug 1;282(2):219-227. doi: 10.1097/SLA.0000000000006570. Epub 2024 Oct 22. PMID 39435556
• Patel V, Dohler M, Marescaux J, Saikali S, Gamal A, Reddy S, Rogers T, Patel E, Oliva R, Satava R, Moschovas MC. Expanding Surgical Frontiers Across the Pacific Ocean: Insights from the First Telesurgery Procedures Connecting Orlando with Shanghai in Animal Models. Eur Urol Open Sci. 2024 Oct 21;70:70-78. doi: 10.1016/j.euros.2024.09.009. eCollection 2024 Dec. PMID 39502103
• Dohler M, Saikali S, Gamal A, Moschovas MC, Patel V. The crucial role of 5G, 6G, and fiber in robotic telesurgery. J Robot Surg. 2024 Nov 16;19(1):4. doi: 10.1007/s11701-024-02164-6. PMID 39549181
• Moschovas MC, Saikali S, Dohler M, Patel E, Rogers T, Gamal A, Marquinez J, Patel V. Advancing Telesurgery Connectivity Between North and South America: the first Remote Surgery Conducted Between Orlando and Sao Paulo in Animal Models. Int Braz J Urol. 2025 Jan-Feb;51(1):e20240601. doi: 10.1590/S1677-5538.IBJU.2024.0601. No abstract available. PMID 39556854
• Patel V, Moschovas MC, Marescaux J, Satava R, Dasgupta P, Dohler M. Telesurgery collaborative community working group: insights about the current telesurgery scenario. J Robot Surg. 2024 May 31;18(1):232. doi: 10.1007/s11701-024-01995-7. No abstract available. PMID 38819496
• Patel V, Marescaux J, Covas Moschovas M. The Humanitarian Impact of Telesurgery and Remote Surgery in Global Medicine. Eur Urol. 2024 Aug;86(2):88-89. doi: 10.1016/j.eururo.2024.04.029. Epub 2024 May 18. PMID 38762391

Идентификаторы

NCT: NCT07130708 · 2294288

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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