Pulmonary Disease Clinical Trial
Official title:
A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery
The objective of this clinical study is to evaluate the safety of the Progel® PALS,
including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative
air leaks in patients undergoing video assisted or robotic assisted thoracoscopic
(VATS/Robotic) surgeries.
The data collected in this clinical study will supplement the Approved PMA P010047 Progel®
PALS product.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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