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Keep this study
Lead
Ethicon Endo-Surgery
This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure details and perioperative outcomes associated with VATS lung resections were also evaluated.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
Performance status 0-1 (Eastern Cooperative Oncology Group classification);
ASA score ≤ 3;
No prior history of VATS or open lung surgery;
Willing to give consent and comply with study-related evaluation and treatment schedule; and
At least 19 years of age.
You may not be if
Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, (within 30 days prior to study procedure);
Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure;
Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
Pregnancy;
Physical or psychological condition which would impair study participation;
The patient is judged unsuitable for study participation by the Investigator for any other reason; or
Unable or unwilling to attend follow-up visits and examinations.
Clareo Health | Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea
