Status:
COMPLETED
Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
Lead Sponsor:
C. R. Bard
Conditions:
Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 un...
Detailed Description
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 R...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT01867658
Start Date
June 1 2013
End Date
April 1 2014
Last Update
March 29 2017
Active Locations (15)
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1
Cardiothoracic & Vascular Surgical Associates, PA
Jacksonville, Florida, United States
2
Jupiter Medical Center, Inc.
Jupiter, Florida, United States
3
Baptist Hospital of Miami
Miami, Florida, United States
4
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, United States