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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 is a NA study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03076931
The ClinicalTrials.gov registry entry for NCT03076931 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Microlaryngoscopy is the first listed.
NCT03076931 reports 0 study locations.
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.
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