NCT01867658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 11, 2016

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

May 3, 2013

Results QC Date

June 15, 2016

Last Update Submit

February 21, 2017

Conditions

Pulmonary Disease

Keywords

Pleural Air LeakPulmonary resectionVideo AssistedRobotic Assisted

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up

    One (1) month

  • Percentage of Air Leaks That Are Sealed or Reduced

    Day 0

  • Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery

    Day 0

  • Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals

    Day 0-46

  • Duration of Chest Tube Drainage

    Day 0-46

  • +2 more secondary outcomes

Study Arms (1)

Progel® Pleural Air Leak Sealant

EXPERIMENTAL
Device: Progel® Pleural Air Leak Sealant

Interventions

Progel® Pleural Air Leak SealantDEVICE

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

Progel® Pleural Air Leak Sealant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Cardiothoracic & Vascular Surgical Associates, PA

Jacksonville, Florida, United States

Location

Jupiter Medical Center, Inc.

Jupiter, Florida, United States

Location

Baptist Hospital of Miami

Miami, Florida, United States

Location

H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

Tampa, Florida, United States

Location

North Shore University Health System

Evanston, Illinois, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

Washington University

St Louis, Missouri, United States

Location

Integrated Cardiology Group, LLC

Lincoln, Nebraska, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, United States

Location

Trustees of Columbia University, NY - Presbyterian Hospital

New York, New York, United States

Location

Greenville Hospital System

Greenville, South Carolina, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Location

INOVA Health Care Services

Falls Church, Virginia, United States

Location

Dean Foundation for Health, Research, and Eduation, Inc

Madison, Wisconsin, United States

Location

Related Publications (1)

  • 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.

    PMID: 27955681DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

Title
Dawn Heimer
Organization
C.R. Bard Inc.
Dawn.Heimer@crbard.com
401-825-8681

Study Officials

  • Bernard Park, MD

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

  • John Snider, MD

    Dean Foundation for Health, Research and Education, Inc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

June 4, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 29, 2017

Results First Posted

November 11, 2016

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(15)