PleuraSeal Post Market Study (Europe) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pulmonary Lobectomy	Device: PleuraSeal Lung Sealant System Procedure: Standard Tissue Closure Techniques	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Prospective Multi-Center Randomized Post Market Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy

Further study details as provided by Confluent Surgical:

Primary Outcome Measures:

Proportion of subjects remaining air leak free from time of skin closure to hospital discharge. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 PleuraSeal Lung Sealant System	Device: PleuraSeal Lung Sealant System PleuraSeal Lung Sealant System
2: Active Comparator Standard tissue closure techniques (control)	Procedure: Standard Tissue Closure Techniques Standard Tissue Closure Techniques

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Elective pulmonary lobectomy and segmentectomy via open thoracotomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704171

Contacts


Contact: Jennifer Doyle	781-839-1770

Locations


United States, Massachusetts
	Jennifer Doyle	Recruiting
	Waltham, Massachusetts, United States, 02451
	Contact: Jennifer Doyle 781-839-1770

Sponsors and Collaborators

Confluent Surgical

Covidien

More Information

Responsible Party:	Confluent Surgical / Covidien ( Jennifer Doyle - Director, Clinical Affairs )
Study ID Numbers:	LUN-06-002
First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704171
Health Authority:	Belgium: Medical Ethics Committee of the University Hospitals of The Catholic University Leuven

Keywords provided by Confluent Surgical:

Elective pulmonary resection via open thoracotomy.

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	Confluent Surgical Covidien
Information provided by:	Confluent Surgical
ClinicalTrials.gov Identifier:	NCT00704171