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Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection

NCT04317924 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-08-26

No results posted yet for this study

Summary

Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost.

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.

Conditions

  • Air Leak From Lung

Interventions

DEVICE

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.

OTHER

Standard of care

Standard of care after air leak post lung resection

Sponsors & Collaborators

  • Gunze Limited

    collaborator OTHER

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Kei Suzuki, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04317924 on ClinicalTrials.gov