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Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection

NCT03450265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2020-04-06

No results posted yet for this study

Summary

This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil.

Conditions

  • Air Leak From Lung

Interventions

DEVICE

Hemopatch

Applied according to the current instruction for use (IFU). According to the IFU, a maximum of 7 Hemopatch 45 x 90 mm patches can be used in adults.

DEVICE

Tachosil

Applied according to the current instruction for use (IFU).

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2019-07-09
Completion
2019-07-09

Countries

  • Italy
  • 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 NCT03450265 on ClinicalTrials.gov