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SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

NCT02668978 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2019-09-04

No results posted yet for this study

Summary

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.

Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."

Conditions

  • LUNG DISEASES

Interventions

DEVICE

Hemopatch™ Sealing Hemostat

Hemopatch™ application over lung resection areas

PROCEDURE

Standard surgical technique

Lung resuturing or restapling

Sponsors & Collaborators

  • Baxter BioScience

    collaborator INDUSTRY

  • Quirón Madrid University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • Spain

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 NCT02668978 on ClinicalTrials.gov