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

Completed · Not applicable

Conditions studied: Pulmonary Disease

In brief

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.

Key facts

Study ID: NCT01867658
Run by: C. R. Bard
People needed: 207
Starts: 2013-06-01
Expected to finish: 2014-04-01
Last updated by the study team: 2017-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Cardiothoracic & Vascular Surgical Associates, PA — Jacksonville, Florida, United States
Jupiter Medical Center, Inc. — Jupiter, Florida, United States
Baptist Hospital of Miami — Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. — Tampa, Florida, United States
North Shore University Health System — Evanston, Illinois, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University — St Louis, Missouri, United States
Integrated Cardiology Group, LLC — Lincoln, Nebraska, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Trustees of Columbia University, NY - Presbyterian Hospital — New York, New York, United States
Greenville Hospital System — Greenville, South Carolina, United States
Baylor Research Institute — Dallas, Texas, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
INOVA Health Care Services — Falls Church, Virginia, United States
Dean Foundation for Health, Research, and Eduation, Inc — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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