PleuraSeal Pivotal Study (US)

NCT ID: NCT00748124

Last Updated: 2014-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-04-30

Brief Summary

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To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.

Detailed Description

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Conditions

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Open Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PleuraSeal Sealant Device

Group Type EXPERIMENTAL

PleuraSeal Sealant System

Intervention Type DEVICE

Lung Sealant Device + standard tissue closing techniques (sutures/staples)

Standard Tissue Closure Techniques

Intervention Type PROCEDURE

Standard tissue closure techniques (sutures/ staples) alone

Control

Group Type OTHER

Standard Tissue Closure Techniques

Intervention Type PROCEDURE

Standard tissue closure techniques (sutures/ staples) alone

Interventions

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PleuraSeal Sealant System

Lung Sealant Device + standard tissue closing techniques (sutures/staples)

Intervention Type DEVICE

Standard Tissue Closure Techniques

Standard tissue closure techniques (sutures/ staples) alone

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Integra LifeSciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Confluent Surgical

Bedford, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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LUN-06-001

Identifier Type: -

Identifier Source: org_study_id

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