A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis

Официальное название

A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis: Expanding Access to Care in Free Tissue Transfer Surgery and Lymphatic Surgery

Обзор

The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: * Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. * Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. * Participants will be asked to comply with the follow-up visits as outlined in the protocol.

Вмешательства

• Устройство Symani Surgical System
  The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.

Первичные конечные точки

• Clinical Success, defined as intraoperative anastomosis patency. [Срок оценки: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).]
• Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. [Срок оценки: The duration of the participants' index procedure hospitalization (typically lasting under two weeks).]

Вторичные конечные точки (3)

• Freedom from a reoperation to revise a robotic anastomosis prior to discharge [Срок оценки: The duration of the participants' index procedure hospitalization (typically lasting under two weeks).]
• Rate of intra-operative approach changes from robotic to manual [Срок оценки: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).]
• Technical success [Срок оценки: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).]

Критерии участия

Критерии включения

• Adults, according to the local law
• Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
• Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and/or lymphedema surgery
• Investigator considers candidate acceptable for free flap transfer surgery and/or lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU

Inclusion Criteria for Therapeutic Lymphatic Patients:

• For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)
• For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):

• Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other
• Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units
• Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening
• Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration
• Patient must be diagnosed with Lymphedema
• Patient must have a body mass index (BMI) of ≤ 35

Inclusion Criteria for Prophylactic Lymphatic Patients:

• In the opinion of the investigator, the patient has at least one identifiable indication for prophylactic lymphatic surgery.
• Patient must have a body mass index (BMI) of ≤ 35

Критерии исключения

• Patients who are not capable and/or unwilling to provide informed consent
• Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion.
• Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
• Patients with implanted pacemaker
• Planned vein graft (either venous or arterial)
• Previously documented history of chronic kidney disease (eGFR ≤ 30)
• Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
• Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator

Exclusion Criteria for Free Tissue Transfer Patients:

• Patients with buried flaps
• Multiple flaps planned for the procedure

Exclusion Criteria for Therapeutic Lymphatic Patients:

• Patients with venous edema (arising from increased capillary filtration)
• Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
• Current infection in the affected area of lymphedema
• Current evidence of malignancy
• Known iodine sensitivity
• Patient's lymphatic disease is due to lipedema
• Patients with bilateral lymphedema or lymphedema in multiple anatomical locations

Exclusion Criteria for Prophylactic Lymphatic Participants:

• Patients for whom prophylactic surgery on more than one limb is planned
• Known iodine sensitivity
• Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator
• Patients diagnosed with lymphedema
• Patients who have received prior radiation therapy to the affected limb where the investigator believes the amount or extent of radiation could compromise the success of prophylactic lymphatic surgery

Intraoperative Exclusion Criteria:

• Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest
• The patient does not have at least two robotic sutures attempted during the index procedure

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

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06628219 · CDC-00134

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗