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

NCT ID: NCT01867658

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-04-30

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.

Conditions

Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Progel® Pleural Air Leak Sealant

Group Type: EXPERIMENTAL

Progel® Pleural Air Leak Sealant

Intervention Type: DEVICE

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

Interventions

Progel® Pleural Air Leak Sealant

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Park, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

John Snider, MD

Role: PRINCIPAL_INVESTIGATOR

Dean Foundation for Health, Research and Education, Inc

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27955681 (View on PubMed)

Other Identifiers

NEO12-102

Identifier Type: -

Identifier Source: org_study_id