Clinical Trials Logo
  1. Home
  2. Pulmonary Surgical Procedures
  3. NCT00925444

Staple-line Reinforcement for Prevention of Pulmonary Air Leakage — SPIRAL  

Lung Neoplasms Clinical Trial

Official title:
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.

Clinical Trial 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).

Clinical Trial Description

Air leaks continue to be the most common complication after pulmonary resection even using a stapling device. Double chest tubes after lobectomy is a well established method for drainage of the pleural cavity to allow adequate expansion of the remaining lung.

FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention of air leakage after pulmonary resection with stapling device. It acts as a suture reinforcement as well as a sealant thanks to its jellification.

Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with sealants.

This is a multi centre, prospective controlled and randomised clinical study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00925444
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 4
Start date June 2009
Completion date March 2013
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03357094 - Pulmonary Ventilation/Perfusion Imaging for the Prediction of Postoperative Residual Pulmonary Function N/A
Recruiting NCT05543954 - 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients Early Phase 1
Completed NCT01114958 - Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases Phase 1
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Active, not recruiting NCT02514512 - Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking N/A
Completed NCT02531737 - Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer Phase 2
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Active, not recruiting NCT02284633 - Blood Sample Monitoring of Patients With EGFR Mutated Lung Cancer
Completed NCT02106143 - RejuvenAir™ System Lobectomy Safety and Histology Study N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Enrolling by invitation NCT01687647 - Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure Phase 3
Terminated NCT00356525 - Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor Phase 2
Completed NCT00351962 - Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours N/A
Completed NCT00385177 - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors Phase 1
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Withdrawn NCT00090701 - A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Recruiting NCT01789229 - Establishment of a Tumor Bank for Tissue Samples