Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery

This is a prospective, open label, multi-center clinical study designed to assess the safety
of the Progel® PALS product, including the Extended Applicator Spray Tip, when used in Video
Assisted and Robotic Assisted Thoracoscopic Surgery. The study will treat approximately 105
evaluable subjects at up to 15 U.S. sites. All subjects will provide informed consent prior
to enrollment in the study.

Patients who have met the initial screening criteria and who have a visible pleural air leak
which requires treatment with a sealant, after standard closure techniques are used
(standard sutures, staples or devices supplied by the hospital for thoracoscopic surgery)
will be eligible for study participation. If the subject is treated, the surgeon will
utilize Progel® PALS to the same sites originally treated with standard technique.

Inclusion Criteria:

- Subject is willing and able to provide written informed consent.

- Subject is scheduled for video assisted or robotic assisted thoracoscopic surgery for
lung resection (i.e. lobectomy, bilobectomy, segmentectomy, and wedge resection/lung
volume reduction), decortications or biopsy within 45 days of the screening
evaluation.

- Subject is ≥18 years of age.

- Subject has a life expectancy ≥6 months.

- 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.

- 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.

Exclusion Criteria:

- Subject has undergone previous lung resection or previous use of a sealant for air
leaks.

- Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.

- Following lung resection, subject has intraoperative air leaks that require
non-standard, visceral pleural closure (e.g. leak is too small or tissue is too
fragile to use sutures/staples).

- Subject has any condition that, in the opinion of the Investigator, would preclude
the use of the study device, or preclude the subject from completing the follow-up
requirements.

- Subject has known allergy to human albumin or any component in the Progel® PALS
product.

- Subject has an active or latent infection which is systemic or at the intended
surgery site.

- Subject has necrotic or friable borders of the defect that will not support secure
suture fixation if use of sutures is required.

- Subject is participating in another investigational drug or device trial.

- Subject is pregnant or has plans to become pregnant during the study period or is
currently breastfeeding.

- Subject is part of the site personnel directly involved with this study.

- Subject is a family member of the investigational study staff.