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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867658
• Other study ID #: NEO12-102
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: May 21, 2014
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Disease

Intervention

Device:
• Progel® Pleural Air Leak Sealant
Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of device and/or procedure-related adverse events	The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.	One (1) month follow-up	Yes
Secondary	Proportion of subjects without postoperative air leaks following lung surgery up to one (1) month follow-up	Key Secondary Endpoint	One (1) month	No
Secondary	Proportion of air leaks that are sealed or reduced		Day 0	No
Secondary	Proportion of subjects who are free from air leaks immediately following surgery		Day 0	No
Secondary	Duration of postoperative air leaks from the time of surgery until the air leak seals		Day 0-7	No
Secondary	Duration of chest tube drainage		Day 0-7	No
Secondary	Duration of hospitalization (length of stay)		Up to Seven (7) Days	No
Secondary	Patient reported Quality of Life as measured by the SF-36		One (1) Month	No