A Prospective Multi-Center Clinical Study to Evaluate the Saftey of Progel Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery
This study is being conducted to collect clinical data to support the use of the Progel PaLS product and the Progel Pleural air Leak Sealant applicator Spray Tip in both Video assisted and Robotic assisted Thoracotomy Surgeries without restriction on leak size.
This study does not involve randomization or treatment arms. if patients meet eligibility intra-operatively the surgeon will use Progel Pleural air Leak Sealant.
The primary endpoint of this study is the rate of device- and/or procedure-related adverse events defined as any adverse event assessed as definitely- or possibly-related to the study device and/or procedure reported through one (1) month of postoperative follow-up. assessment of adverse events will also be obtained.
This study will also assess the following secondary endpoints:
1. Proportion of air leaks that are sealed or reduced, as demonstrated by the air leak test (see Section 6.2.2), prior to completion of the lung surgery.
2. Proportion of subjects who are free from air leaks immediately following surgery as measured by the presence of air leaks from the chest tube at the first postoperative time point once the subject is in the recovery room.
3. Duration of postoperative air leaks from the time of surgery until the air leak seals.
4. Duration of chest tube drainage.
5. Duration of hospitalization (length of stay).
6. Patient reported Quality of Life as measured by the SF-36.
1. Subject is willing ans able to provide written informed consent.
2. Subject is scheduled for video assisted or robotic assisted thoracotomy for lung surgery (i.e. lobectomy, bilobectomy, segmentectomy, and wedge resection/lung volume reduction), decortications or biopsy within 45 days of the screening evaluation.
3. Subject is greater than or equal to 18 years of age.
4. Subject has a life expectancy greater than or equal to 6 months.
5. Following lung resection, subject has at least one or more visible intraoperative air leaks, after standard closure techniques are applied that requires treatment with pleural sealant.
6. Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including the follow-up visits.