A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Medias… (NCT05455840) | Clinical Trial Compass
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A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease
Taiwan15 participantsStarted 2022-08-03
Plain-language summary
Endpoints (Outcome measures)：
1. Primary endpoint: Incidence of conversion rate during surgery
\- The primary performance endpoint will be assessed as the ability to successfully complete the planned mediastinal procedure with da Vinci SP System, with no conversion to open surgery, video-assisted thoracoscopic surgery (VATS), multi-port robotic surgery or approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. Use of additional assistant port(s) is not considered a conversion
2. Secondary endpoints: Incidence of treatment related adverse events - The safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow up period
Who can participate
Age range20 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age \>20 and \<75 years-old
✓. Willing and able to provide informed consent
✓. ASA≤ 3
✓. The subject fulfills one or both of the following criteria:
✓. Class I-IV Myasthenia gravis according to the Myasthenia Gravis Foundation of America Scientific Session (MGFA)
Exclusion criteria
✕. Congestive heart failure (NHYA \> II)
✕. Arrhythmia required medication control
✕. Subjects with a known bleeding or clotting disorder
✕. Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation
✕. Subjects under immunomodulatory within 30 days prior to the planned surgery
. Previous ipsilateral thoracic surgery or sternotomy
✕. Uncontrolled illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
✕. Previous neoadjuvant medical and/or radiation therapy