NCT02796326

Brief Summary

The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

June 1, 2016

Last Update Submit

October 27, 2017

Conditions

Tracheal Stenosis

Keywords

tracheal stenosistracheal dilatationventilation

Outcome Measures

Primary Outcomes (2)

  • Incidence of peripheral arterial desaturation

    Incidence of desaturation below 90% as measured by peripheral pulse oximeter

    During procedure (up to 60 minutes duration)

  • Time to desaturation

    Time to desaturation below 90% as measured by peripheral pulse oximeter

    During procedure (up to 60 minutes duration)

Secondary Outcomes (2)

  • Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading

    During procedure (up to 60 minutes duration)

  • Incidence of major adverse events

    During and within 24 hours of procedure

Study Arms (1)

Dilatation

EXPERIMENTAL

Patients undergoing tracheal dilatation with the study device

Device: improved tracheal balloon dilatation

Interventions

improved tracheal balloon dilatationDEVICE

Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon

Also known as: tracheal balloon dilatation
Dilatation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Symptoms of tracheal or laryngeal stenosis or airway narrowing
  • Endoscopic evidence of subglottic or tracheal stenosis
  • Able to provide informed consent

You may not qualify if:

  • Refractory stenosis not amenable to balloon dilatation
  • Contraindication to balloon dilatation
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Tracheal StenosisRespiratory Aspiration

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthesiologist and Clinical Research Fellow in Airway and Thoracic Anaesthesia

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 10, 2016

Study Start

October 1, 2016

Primary Completion

June 30, 2017

Study Completion

September 30, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

Locations

ZA(1)