Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection
NCT ID: NCT04317924
Last Updated: 2020-08-26
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2020-10-31
2022-06-30
Brief Summary
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NeoVeil is a bioabsorbable glycolic acid which has been used in Japan and other Asian countries for air leak prevention after lung resections. NeoVeil is impregnated with fibrin sealant materials and is placed on the lung surface at the time of operation. It then acts as a scaffold on resected area which is prone to air leak.
This randomized clinical trial will be the first in the United States to test its efficacy for air leak prevention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Reinforcement of air leak
Participants in this arm will receive reinforcement with the NEOVEIL (polyglycolic acid felt) which will be impregnated with human fibrinogen and thrombin.
Polyglycolic acid felt
Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.
No reinforcement of air leak
Participants in this arm will receive standard of care for air leak post lung resection.
Standard of care
Standard of care after air leak post lung resection
Interventions
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Polyglycolic acid felt
Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.
Standard of care
Standard of care after air leak post lung resection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intra-operative diagnosis of air leak
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Gunze Limited
OTHER
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Kei Suzuki, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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H-37652
Identifier Type: -
Identifier Source: org_study_id
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