Status:

UNKNOWN

Endotracheal Dilator to Improve Oxygenation

Lead Sponsor:

University of Cape Town

Collaborating Sponsors:

Red Cross War Memorial Children's Hospital

Conditions:

Tracheal Stenosis

Airway Disease

Eligibility:

All Genders

Up to 13 years

Phase:

NA

Brief Summary

The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator in children (\<13 years old) with subglottic or tracheal stenosis. The hypothesis is that the device ...

Detailed Description

This study is a prospective, single arm, observational study of patients at Red Cross War Memorial Children's Hospital receiving treatment for laryngotracheal stenosis using a modified tracheal dilata...

Eligibility Criteria

Inclusion

  • Refractory stenosis not amenable to balloon dilatation
  • Contraindication to balloon dilatation (long-segment stenosis)
  • Patient refusal

Exclusion

  • Refractory stenosis not amenable to balloon dilatation
  • Contraindication to balloon dilatation (long-segment stenosis)
  • Patient refusal

Key Trial Info

Start Date :

September 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2018

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03411928

Start Date

September 1 2018

End Date

December 30 2018

Last Update

May 2 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Groote Schuur Hospital

Cape Town, Western Cape, South Africa, 7925