SP Thoracic IDE Study

Korábbi kezelés

• Uncontrolled systemic 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 chemotherapy, immunotherapy and/or radiation therapy for treatment of the cancer to be resected
• Subject has a contraindication for general anesthesia or surgery
• Subjects under active immunomodulatory or immunosuppressive regimen (e.g. transplant patient, high-dose steroid requirement) within 30 days prior to the planned surgical procedure. For myasthenia patients, if steroids are weaned down to prednisone ≤ 5 mg/day prior to day of surgery, the patient may be enrolled
• Previous sternotomy
• Tumor involving carina or any airway requiring sleeve resection, bronchoplasty
• Tumor requiring resection of local structures (e.g. chest wall) or extended resection such as bilobectomy
• Previous ipsilateral thoracic surgery or radiotherapy
  • Thymectomy Exclusion Criteria:
• Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery
• Tumor requiring resection of local structures (except pericardium)
• Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery

Más betegség

• Clinical or radiological evidence of mediastinal or systemic metastatic disease
• Subject with a known bleeding or clotting disorder
• History of pulmonary hypertension

Laborértékek

• Subjects actively receiving therapeutic-dose anticoagulation or anti-platelet medications at the time of operation

Egyéb

• Life expectancy < 6 months
• Subject belongs to vulnerable population
• Subject is pregnant or suspected to be pregnant or breastfeeding
  • Lobectomy Exclusion Criteria:
• Confirmed thymic carcinoma
  • Intraoperative Exclusion Criteria:

• Age > 21 years
• BMI ≤ 35
• ASA ≤ 3
• Willing and able to provide a written informed consent
• Willing and able to comply with the study protocol requirements including follow-up examinations at 14 days and 30 days post-operatively, and post-market long term follow-up on an annual basis through 5 years
  • Lobectomy Inclusion Criteria:
• Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter
  • Thymectomy Inclusion Criteria:
• Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter