Study Summary
This trial will test a new type of vocal cord implant to see if it is safe and effective for treating patients with paralysis of one vocal cord. Up to 30 patients will be enrolled.
- Unilateral Vocal Cord Paralysis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 7weeks
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: APrevent® VOIS-Implant · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What standards must be met to participate in this research?
"This clinical trial is seeking thirty participants between the ages of eighteen and eighty with laryngeal paralysis. To be eligible, applicants must display a palpable voice disorder (a GRBAS Grade ≥2 or VHI-30 score >33), comprehend the full purpose of this study including potential risks, and have the capability to comply with all requirements throughout its duration." - Anonymous Online Contributor
Is there currently an open enrollment period for this investigation?
"Confirmed, clinicaltrials.gov details that this medical trial is still in need of participants since its initial posting on November 13th 2019 and most recent update on November 4th 2021. 30 individuals are desired to be recruited from a single facility." - Anonymous Online Contributor
Is the age limit for applicants to this research study set at 75 years or above?
"Individuals between 18 and 80 years of age can take part in this research." - Anonymous Online Contributor
How many participants can join the experiment?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial is still enrolling participants, the original posting of which dates back to November 2019 and was most recently modified on November 2021. This study requires 30 human subjects from a single medical centre." - Anonymous Online Contributor