NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

C. R. Bard444 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

444

Conditions

Lung Cancer Lung Tumor

Interventions

ControlOTHER

Standard surgical techniques including staples and sutures.

ProGEL Pleural Air Leak Sealant with standard surgical closureDEVICE

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). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.

ProGEL Pleural Air Leak Sealant without standard surgical closureDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

St. Vincent Birmingham & St. Vincent East

Birmingham, Alabama, United States

University of Alabama in Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Safety Endpoints

* 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

Time frame: 90 days

Data from ClinicalTrials.gov

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