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NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

This study is currently recruiting participants.
Verified May 2011 by Neomend, Inc.
Sponsor:
Information provided by:
Neomend, Inc.
ClinicalTrials.gov Identifier:
NCT01394978
First received: July 13, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lung Resection
Open Thoracotomy
 Other: Standard surgical techniques
Device: Standard surg. techniques plus ProGEL Pleural Air Leak Sealant
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Neomend, Inc.:

Primary Outcome Measures:
  • Safety endpoints [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control Other: Standard surgical techniques
Surgical techniques including staples, sutures and cautery.
ProGEL Pleural Air Leak Sealant Device: Standard surg. techniques plus 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.

  Eligibility

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

Inclusion Criteria:

  • Scheduled for an open thoracotomy for lung resection
  • Has at least one or more intraoperative visible air leak 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
  • ECOG performance status score
  • Had previous open thoracotomy procedures
  • Unable to participate in all necessary study activities due to physical or mental limitations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394978

Contacts
Contact: Mark Barakat, MD 949-783-3463 mark.barakat@neomend.com

Locations
United States, Alabama
University of Alabama in Birmingham Recruiting
Birmingham, Alabama, United States, 35894
Contact: Ashlee Rawlins, BS     205-996-7561        
Principal Investigator: Robert J. Cerfolio, MD            
Sub-Investigator: Ayesha Bryant, MD            
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jennifer Noel Walker, RN, BSN     404-778-2198        
Principal Investigator: Daniel L. Miller, MD            
Sponsors and Collaborators
Neomend, Inc.
Investigators
Principal Investigator: Robert J. Cerfolio, MD University of Alabama in Birmingham
Principal Investigator: Daniel L. Miller, MD Emory University
  More Information

No publications provided

Responsible Party: Pam Misajon/Vice President RA/CA/QA, Neomend, Inc.
ClinicalTrials.gov Identifier: NCT01394978     History of Changes
Other Study ID Numbers: NEO09-100
Study First Received: July 13, 2011
Last Updated: July 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Neomend, Inc.:
Pleural air leak
Pulmonary resection
Open thoracotomy

ClinicalTrials.gov processed this record on May 16, 2013