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NCT03076931 · ClinicalTrials.gov registry record · NA
Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT03076931: Clinical Trial NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03076931 is a NA study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03076931, a NA study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Objective: The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an imaging biomarker to support diagnosis and predict vibratory outcome after airway reconstruction. Our protocol will involve eliciting and recording the following five behaviors: (1) hard throat clear; (2) cough; (3) laugh; (4) short multiple phonations; and (5) sustained phonation. These HSV recordings will be used to develop the biomarkers. Study Design: A prospective cohort study of 60 patients, 36 who will undergo airway reconstruction and 24 age matched controls. Setting: Center for Pediatric Voice Disorders, Department of Otolaryngology, Cincinnati Children's Hospital Medical Center Methods: Subjects will undergo a full voice evaluation, including an HSV evaluation protocol, at the main study site prior to airway reconstruction, 6 months post and 1 year post surgery. Voice evaluation will include aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and HSV. The airway evaluation will include airway sizing and calibration.
Primary Outcome
Vibratory source will be rated by having HSV imaging samples subjected to an automatic temporal segmentation, which will extract the HSV segment of interest. The extracted temporal segment (i.e. token) is subjected to an automatic image segmentation based on the oscillating edges of the anatomic structures using kymographic paired active contours. The image segmentation will be aided by an automatic spectral oscillation analysis similar to previously published methods. Three raters will be asked
Interventions
- PROCEDURE Microlaryngoscopy
- PROCEDURE Voice Evaluation
- PROCEDURE Airway Reconstruction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2019-10-15 |
| Phase | NA |
Why NCT03076931 stopped before completion
NCT03076931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Microlaryngoscopy is the first listed.
NCT03076931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03076931 about?
NCT03076931 is a clinical study titled "Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction". Objective: The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an imaging biomarker to support diagnosis and predict vibratory outcome after airway reconstruction. Our protocol will involve eliciting and recording the following five behaviors: (1) hard throat ...
What is the current status of trial NCT03076931?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2016-08-01. Estimated completion is 2019-10-15.
What interventions are being tested in trial NCT03076931?
The interventions under investigation include: Microlaryngoscopy (PROCEDURE), Voice Evaluation (PROCEDURE), Airway Reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT03076931?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03076931's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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