New treatment option for Surgery
Official title Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
ClinicalTrials.gov ID: NCT06439290
What this study is testing
- What it's testing
- The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- PURPOSE 1: for surgery participants:
- Persons who will soon undergo surgery on the vocal folds and/or larynx (including glottoplasty, cricothyroid approximation, thyroplasty and/or...
- At least 18 years old
- Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires for volunteers to provide...
- Dutch-speaking
You likely can't join if
- for the healthy participants:
- \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
- Inclusion criteria for the pre- and postoperative MRI participants:
- \- Random selection of +- 10 participants of purpose 1.
- Exclusion criteria for the pre- and postoperative MRI participants:
- \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
See the full eligibility criteria
- PURPOSE 1: for surgery participants:
- Persons who will soon undergo surgery on the vocal folds and/or larynx (including glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty) at UZ Gent
- At least 18 years old
- Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires for volunteers to provide speech samples: \- Cisgender men or women for volunteer listeners for...
- Dutch-speaking
- Self-reported normal hearing PURPOSE 2: same as above. PURPOSE 3: for the healthy participants:
- At least 18 years old
- Sufficient command of the Dutch language to complete a Dutch questionnaire
- for the healthy participants:
- \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
- Inclusion criteria for the pre- and postoperative MRI participants:
- \- Random selection of +- 10 participants of purpose 1.
- Exclusion criteria for the pre- and postoperative MRI participants:
- \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, East-Flanders, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, East-Flanders, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.