PleuraSeal Pivotal Study (US)

A Prospective Multicenter Randomized Clinical 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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00748124

Enrollment

230

Registered

2008-09-08

Start date

2008-08-31

Completion date

2011-04-30

Last updated

2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Thoracotomy

Brief summary

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.

Interventions

DEVICEPleuraSeal Sealant System

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

PROCEDUREStandard Tissue Closure Techniques

Standard tissue closure techniques (sutures/ staples) alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.	75 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026