PleuraSeal Post Market Study (Europe) (NCT00704171) | Clinical Trial Compass
CompletedPhase 4
PleuraSeal Post Market Study (Europe)
United States, Austria, Belgium121 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pre-Operative Inclusion Criteria:
* 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
Pre-Operative Exclusion Criteria:
* 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 contrace…
What they're measuring
1
Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
Timeframe: 30 days
2
Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge