PleuraSeal Pivotal Study (US)

Phase 3TerminatedNCT00748124

Integra LifeSciences Corporation230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

230

Conditions

Open Thoracotomy

Interventions

PleuraSeal Sealant SystemDEVICE

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

Standard Tissue Closure TechniquesPROCEDURE

Standard tissue closure techniques (sutures/ staples) alone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy

Locations (1)

Confluent Surgical

Bedford, Massachusetts, United States

Outcomes

Primary Outcomes

Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.

Time frame: 75 days

Data from ClinicalTrials.gov

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