NCT02364791

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

A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	standard techniques used to achieve air leak control
DEVICE	Hemopatch

Timeline

• Start date: 2015-02-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2015-02-18
• Last updated: 2023-03-24

Locations

1 site across 1 country: Italy