MedTrace Logo

A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

NCT02364791 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-03-24

No results posted yet for this study

Summary

The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.

Conditions

  • Thoracic Surgery Lung
  • Post-operative Thoracic Air Leak

Interventions

DEVICE

standard techniques used to achieve air leak control

DEVICE

Hemopatch

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER

  • Istituto Clinico Humanitas

    collaborator OTHER

  • European Institute of Oncology

    collaborator OTHER

  • Regina Elena Cancer Institute

    collaborator OTHER

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Gaetano Rocco, MD, FRCSEd · National Cancer Institute, Naples

  • Francesco Perrone, MD, PhD · National Cancer Institute, Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT02364791 on ClinicalTrials.gov