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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1
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925