Status:

RECRUITING

Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM

Lead Sponsor:

University Hospital, Toulouse

Conditions:

Airway Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Airway stenting is usually efficient to treat central airway obstruction but can lead to severe and potentially lethal complications (stent migration, obstructive granuloma, perforation, and hemoptysi...

Eligibility Criteria

Inclusion

  • Age \>18 years
  • Informed consent
  • Complex, proximal and symptomatic (dyspnea, cough, peak flow \< 50%, FEV1 \< 50% or post-stenotic infection) airway stenosis

Exclusion

  • Acute respiratory distress, mechanical ventilation
  • Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
  • Pregnancy

Key Trial Info

Start Date :

June 17 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04848025

Start Date

June 17 2021

End Date

December 1 2025

Last Update

November 1 2024

Active Locations (1)

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1

University Hospital Toulouse

Toulouse, Toulouse, France, 31000