At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 380 enrolled
Drug / intervention
FOREseal +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.
Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.
In Brief
A Phase 4 clinical trial evaluating FOREseal and Stapling for Lung Neoplasms and 4 related conditions. Completed, enrolled 380 participants across 1 site.
Detailed Summary
The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer. Hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Neoplasms, Pulmonary Surgical Procedures, Surgical Staplers, Tissue Adhesives, Chest Tubes
CountriesFrance
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionMar 2013
TodayJul 2026
First PostedJun 22, 2009
Enrollment StartJun 1, 2009
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.0 years ago
Interventions
FOREsealdevice
a pair of alginate sleeves for linear cutting staplers used in lung surgery
Staplingdevice
Stapling alon or associated with sealants