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Trial record 1 of 1 for:    neomend
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NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394978
First Posted: July 15, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C. R. Bard
July 13, 2011
July 15, 2011
April 17, 2017
July 11, 2017
July 11, 2017
June 2011
February 2016   (Final data collection date for primary outcome measure)
Safety Endpoints [ Time Frame: 90 days ]
  • Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome
  • Renal adverse events
  • Cardiac adverse events
  • Death (all causes)
  • Hospital readmission
Same as current
Complete list of historical versions of study NCT01394978 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure
The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.
Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lung Cancer
  • Lung Tumor
  • Other: Control
    Standard surgical techniques including staples and sutures.
  • Device: ProGEL Pleural Air Leak Sealant
    ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).
  • Control
    No treatment.
    Intervention: Other: Control
  • Experimental: ProGEL Pleural Air Leak Sealant
    Standard surgical technique plus Progel Pleural Air Leak Sealant.
    Intervention: Device: ProGEL Pleural Air Leak Sealant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
444
February 2016
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled for an open thoracotomy for lung resection
  • Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery

Exclusion Criteria:

  • Pregnant or breast feeding
  • History of an allergic reaction to Human Serum Albumin
  • Has a significant clinical disease or condition
  • Had previous open thoracotomy procedures
  • Unable to participate in all necessary study activities due to physical or mental limitations
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01394978
NEO09-100
Yes
Not Provided
Not Provided
C. R. Bard
C. R. Bard
Not Provided
Principal Investigator: Robert J. Cerfolio, MD University of Alabama in Birmingham
Principal Investigator: Daniel L. Miller, MD WellStar Research Institute
C. R. Bard
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP