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.

Currently, Confluent Surgical markets a synthetic, PEG-based hydrogel sealant
in the United States and several geographies outside the United States,
including the European Union. The PMA approved device, marketed under the
trade name *DuraSeal® Dural Sealant System*, is intended for use as an adjunct
to standard methods for dural repair, such as sutures, to provide watertight
closure. Additionally, DuraSeal is CE Mark approved for the following thoracic
indication: to produce a leak-free closure when used during elective pulmonary
resection as an adjunct to standard closure techniques of visceral pleural air
leaks. Based on the physical properties of the sealant, DuraSeal technology may
address shortcomings of other surgical sealants and may provide a safe and
effective alternative for producing leak-free closures when used to augment
primary visceral pleural repairs. The material is biocompatible and inert.
Due to its synthetic nature the material carries no potential for transmitting
blood-borne pathogens or for inducing anaphylaxis. Unlike other polymeric
sealants, it does not require any primers nor does it require an outside energy
source to facilitate the polymerization reaction. Application is simple, with
rapid in situ polymerization (within 3 seconds), making it easy to prepare and
use. Moreover, the PEG polymer structure and high water composition of the
sealant results in a material with low durometer and favorable elastic
properties, ideal for lung applications as the material must contract and
expand with respiration without limiting normal pulmonary function or pleural
surface healing. When used for pulmonary sealing, the DuraSeal material is
referred to as the PleuraSeal* Sealant System.

The purpose of this protocol is to further evaluate the safety and performance
of Confluent Surgical*s PleuraSeal* Sealant System in the treatment and control
of air leaks following elective pulmonary resection via an open thoracotomy.
Results from this study, if favorable, will demonstrate that the PleuraSeal
surgical sealant provides a convenient, safe and effective surgical tool that
can be used as an adjunct to standard closure of visceral pleural air leaks
incurred during elective pulmonary resection.

Objective of the study (in English):

Further characterize the PleuraSeal Sealant System as compared to standard of
care (sutures and staples) in subjects undergoing an elective pulmonary
lobectomy, and segmentectomy (limited resection in case of reduced functional
operability) in one or more lobes via an open thoracotomy.

This is a prospective, multi-center, randomized, two-arm, single-blind post
market study designed to compare standard tissue closure techniques (control)
to standard tissue closure techniques plus the PleuraSeal Sealant System (study
device) for control of intraoperative and postoperative air leaks.
Approximately 120 subjects will be randomized in 1:1 ratio either to control
group or study device treatment group to obtain 112 subjects required to
evaluate the primary endpoint.

This is a prospective, multi-center, randomized, two-arm, single-blind post
market study designed to compare standard tissue closure techniques (control)
to standard tissue closure techniques plus the PleuraSeal Sealant System (study
device) for control of intraoperative and postoperative air leaks.
Approximately 120 subjects will be randomized in 1:1 ratio either to control
group or study device treatment group to obtain 112 subjects required to
evaluate the primary endpoint.

Randomization:

Prior to the initiation of the study, a treatment randomization scheme will be
generated. Treatment assignments will be placed into a sealed envelope (or
other suitable randomization method; e.g., interactive voice response system)
thus blinding the surgeon to treatment assignment prior to randomization. Once
the closure of the pulmonary resection has been completed to the surgeons*
satisfaction and the subject has been confirmed to meet all intra-operative
eligibility criteria, subjects will be randomly assigned to either the
investigational group or the control group. Group assignments will be performed
using a randomization method that will allow for the blinding of the surgeon up
to this point. Randomization will be blocked by study center.

Following completion of the pulmonary resection procedure, once hemostasis has
been achieved, and closure has been completed to the surgeons* satisfaction, a
thorough search for air leaks will be performed. Air leak assessment will be
accomplished while the lung is partially inflated with instillation of warm
sterile saline into the thorax and submersion of the cut or dissected lung
surfaces while maintaining mechanical ventilation with an end-inspiratory
airway pressure of 20 to 25cm H20.
Subject*s intraoperative eligibility will be confirmed following the first lung
submersion leak test. Subjects with no intraoperative leaks will not be
eligible for randomization, but will be followed through hospital discharge in
order to quantify if late air leaks occur. For those subjects the CRF Form
*Late air leak occurrence* needs to be completed. All other subjects that do
not meet intraoperative eligibility criteria will be withdrawn from study
participation and not followed. Subjects will then be randomly assigned on a
one-to-one (1:1) basis to either the study device or control group

If the subject is randomized to the investigational device: The PleuraSeal
Sealant should be applied to all air leaks, areas of dissection, suture and
staple lines and raw parenchymal surfaces. The sealant is to be applied with
the lung partially inflated so that all target application areas are able to be
fully visualized (i.e. no folds in lung tissue) and no active air leaks are
present. After all targeted sites have been adequately treated, and following a
10-20 second gel period at the last treated site, the lung submersion leak test
should be repeated. Up to two applications of sealant will be allowed in
attempt to control air leaks. Each application is defined by the administration
of the lung submersion leak test.

If the subject is randomized to control: The PleuraSeal Sealant will not be
applied and sutures and staples will be the only standard of care used.

For both study groups (control and investigational device): After the assigned
treatment has been completed, a final reassessment and re-grading of air leaks,
using the lung submersion leak test will be performed. If no intraoperative
air leaks are identified it will be considered a success for the secondary
endpoint (i.e. intraoperative sealing success). Inversely, if air leaks are
still present it will be considered a failure for the secondary endpoint.
Investigators are then able to attempt other techniques designed to control the
pleural space, such as pleural tenting or phrenic nerve crush.

Taking part in this study may or may not provide any help to the subject. A
possible benefit of the PleuraSeal is that it may help reduce the possibility
of air leaks and to reduce the problems associated with a leak after lung
surgery. This may include reducing the need for prolonged hospital stays
and/or re-operations.