CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 260 enrolled
Drug / intervention
Hemopatch +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02491671
NCT02491671Phase 3Completed

Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León·interventional·Posted Jul 8, 2015·Updated Aug 9, 2021

In Brief

A Phase 3 clinical trial evaluating Hemopatch and standard preventive measures for Prolonged Air Leak and Lung Resection. Completed, enrolled 260 participants across 6 sites.

Detailed Summary

The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 8, 2015
Enrollment StartNov 24, 2015
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.0 years ago

Interventions

Hemopatchdevice

standard preventive measuresprocedure