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

NCT01867658 · C. R. Bard · Updated 29 March 2017

What is being tested
Progel® Pleural Air Leak Sealant
For
Pulmonary Disease
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 207 people. The full rules are on the registry page.
Where
United States (15 sites)
When
Starts or started June 2013, ends April 2014. Registered 4 June 2013.
Results
Posted on the registry on 11 Nov 2016.

In the researchers' words

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.
ClinicalTrials.gov, NCT01867658

Sites

  • Cardiothoracic & Vascular Surgical Associates, PAJacksonville, Florida, United States
  • Jupiter Medical Center, Inc.Jupiter, Florida, United States
  • Baptist Hospital of MiamiMiami, Florida, United States
  • H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.Tampa, Florida, United States
  • North Shore University Health SystemEvanston, Illinois, United States
  • Mayo ClinicRochester, Minnesota, United States
  • Washington UniversitySt Louis, Missouri, United States
  • Integrated Cardiology Group, LLCLincoln, Nebraska, United States
  • Hackensack University Medical CenterHackensack, New Jersey, United States
  • Trustees of Columbia University, NY - Presbyterian HospitalNew York, New York, United States
  • Greenville Hospital SystemGreenville, South Carolina, United States
  • Baylor Research InstituteDallas, Texas, United States
  • University of Texas Southwestern Medical CenterDallas, Texas, United States
  • INOVA Health Care ServicesFalls Church, Virginia, United States
  • Dean Foundation for Health, Research, and Eduation, IncMadison, Wisconsin, United States