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Staple-line Reinforcement for Prevention of Pulmonary Air Leakage

NCT00925444 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2013-09-18

No results posted yet for this study

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).

Conditions

  • Lung Neoplasms
  • Pulmonary Surgical Procedures
  • Surgical Staplers
  • Tissue Adhesives
  • Chest Tubes

Interventions

DEVICE

FOREseal

a pair of alginate sleeves for linear cutting staplers used in lung surgery

DEVICE

Stapling

Stapling alon or associated with sealants

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean François REGNARD, PhD · Centre Hospitalier Hotel Dieu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • France

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 NCT00925444 on ClinicalTrials.gov