PleuraSeal Post Market Study (Europe)

NCT00704171 | Completed Phase 4 Results

• 1 other identifier: LUN-06-002
• Study Type: interventional
• Target: 121
• Locations: 6 countries
• Sites: 9

Brief Summary

To further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and segmentectomy via open thoractomy.

Conditions

Lung Disease; Pulmonary Lobectomy

Keywords

Elective pulmonary resection via open thoracotomy.

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.

  30 days

• Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge

  Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles

  30 days

Secondary Outcomes (4)

• Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.

  Intra-operatively, time of study procedure

• Time From Skin Closure to Last Observable Air Leak.

  30 days

• Duration of Chest Drainage

  30 days

• Duration of Hospitalization

  30 days

Study Arms (2)

PleuraSeal

EXPERIMENTAL

PleuraSeal Lung Sealant System

Device: PleuraSeal Lung Sealant System

Standard of Care

ACTIVE COMPARATOR

Standard tissue closure techniques (control) - sutures or staples only

Procedure: Standard Tissue Closure Techniques; Device: PleuraSeal Lung Sealant System

Interventions

Standard Tissue Closure Techniques PROCEDURE

Standard Tissue Closure Techniques (sutures and staples only)

Also known as: Sutures or staples

Standard of Care

PleuraSeal Lung Sealant System DEVICE

Also known as: PleuraSeal

PleuraSeal; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years of age or older
• Scheduled for an elective pulmonary lobectomy and segmentectomy (limited resection in case of reduced functional operability) in one or more lobes via an open thoracotomy
• Subject or authorized representative has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Ethics Committee of teh respective clinical site

You may not qualify if:

• Documented history of bleeding disorders and/or severely altered renal or hepatic function
• Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, immunosuppressive therapy)
• Prior ipsilateral thoracotomy
• Subject with Tuberculosis
• Extensive adhesions from previous thoracic trauma or surgery
• Undergoing lung volume reduction surgery, wedge resection, pneumonectomy, sleeve resection or bronchoplasty, blebectomy, bullectomy, pleurodesis, lung transplant, or living lobe transplant donor
• Subject has active systemic or pulmonary infection
• Treated with chronic steroid therapy unless discontinued more than 6 weeks prior to surgery (standard acute perioperative steroids are permitted). For purposes of this protocol, chronic steroid therapy is defined as greater than 4 weeks
• Pregnant (documented by pregnancy test), breast-feeding, or that wish to become pregnant during the course of the study or not willing to use birth control (e.g. IUD; oral, transdermal or parenteral contraceptives; abstinence)
• Documented history of uncontrolled diabetes
• Subject has an estimated life expectancy of less than 6 months
• Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study
• Congestive heart failure, cor pulmonale, or other condition that, in the opinion of the investigator, may jeopardize the subject's well-being and/or negatively impact the interpretation of data collected during the clinical study
• Unable to comply with the study requirements or follow-up schedule
• At least one intra-operative air leak identified during lung submersion leak test after the initial closure is completed

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Medtronic - MITG: collaborator

Study Sites (9)

Covidien

Bedford, Massachusetts, 01730, United States

Location

Universitaetsklinik - Landeskrankenhaus Innsbruck

Innsbruck, Austria

Location

Otto Wagner Spital

Vienna, Austria

Location

Hopital Erasme

Brussels, Belgium

Location

University Hospitals Leuven

Leuven, Belgium

Location

VU-Medisch Centrum

Amsterdam, Netherlands

Location

Medical Centre Rotterdam Zuid

Rotterdam, Netherlands

Location

University Hospital - Zurich

Zurich, Switzerland

Location

Papworth Hospital

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Sutures

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Jennifer L. Doyle, Global Director of Clinical Affairs
• Organization: Covidien

jennifer.doyle@covidien.com

781-839-1770

Study Officials

• Jennifer Doyle

  Senior Director, Clinical Affairs at Covidien (formerly Confluent)

  STUDY DIRECTOR

• Paul De Leyn, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 24, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 27, 2016
• Results First Posted: March 15, 2010

Record last verified: 2016-09

Locations

AU (2); BE (2); NL (2); GB (1); US (1); CH (1)