Clinical trial NCT01867658: Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Keywords: Pleural Air Leak
Pulmonary resection
Video Assisted
Robotic Assisted
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Device and/or Procedure-related Adverse Events
timeFrame: One (1) month follow-up
Secondary outcomes:
measure: Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up
timeFrame: One (1) month
measure: Percentage of Air Leaks That Are Sealed or Reduced
timeFrame: Day 0
measure: Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery
timeFrame: Day 0
measure: Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals
timeFrame: Day 0-46
measure: Duration of Chest Tube Drainage
timeFrame: Day 0-46
measure: Duration of Hospitalization (Length of Stay)
timeFrame: Days 0-20
measure: Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up
timeFrame: Baseline and One (1) Month Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Cardiothoracic & Vascular Surgical Associates, PA
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center, Inc.
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
state: Florida
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Lincoln
country: United States
facility: Integrated Cardiology Group, LLC
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York City
country: United States
facility: Trustees of Columbia University, NY - Presbyterian Hospital
state: New York
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Falls Church
country: United States
facility: INOVA Health Care Services
state: Virginia
city: Madison
country: United States
facility: Dean Foundation for Health, Research, and Eduation, Inc
state: Wisconsin
Study officials:
affiliation: Hackensack Meridian Health
name: Bernard Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dean Foundation for Health, Research and Education, Inc
name: John Snider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park BJ, Snider JM, Bates NR, Cassivi SD, Jett GK, Sonett JR, Toloza EM. Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks. J Cardiothorac Surg. 2016 Dec 12;11(1):168. doi: 10.1186/s13019-016-0563-3.