RECRUITING

APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

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Conditions

Paralysis, Unilateral, Vocal Cord

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned to be enrolled.

Official Title

Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study

Quick Facts

Study Start:2019-11-13
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05119842

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female patients between 18 and 80 years
  2. * Diagnosed with permanent UVFP and insufficient glottal closure
  3. * A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-30 score \>33)
  4. * Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
  5. * Ability to co-operate with the Investigator and to comply with the requirements of the entire study
  6. * Availability to volunteer for the entire study duration, willing to adhere to all protocol requirements and willing and able to give informed consent for participation
  1. * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation
  2. * Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
  3. * Bilateral vocal fold paralysis
  4. * Had injection medialization laryngoplasty with the injectable still being within the double length of the maximum resorption time frame as stated in their approval or as supported by literature.
  5. * Presence of structural vocal fold lesions such as polyp or nodules
  6. * Presence of oropharyngeal or laryngeal tumors
  7. * Patients with diagnosed severe obstructive sleep apnea (OSA)
  8. * Status post total cordectomy
  9. * Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
  10. * Status post tracheostomy
  11. * Presence of acute systemic infection at time of screening or shortly before surgery
  12. * Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
  13. * Severe coagulopathy
  14. * Females who are pregnant, lactating or planning pregnancy are excluded from the investigation
  15. * Patients with bil. Gr. III-IV hypertrophic tonsils
  16. * Diabetes mellitus with poor control and poor wound healing history

Contacts and Locations

Study Contact

Berit Schneider-Stickler, Prof
CONTACT
+ 43-676-842 311 311
office@med4com.at
Matthias Leonhard, Dr
CONTACT
+43 1 404 00 - 33170
matthias.leonhard@meduniwien.ac.at

Principal Investigator

Matthias Leonhard, Dr
PRINCIPAL_INVESTIGATOR
Study principal investigator

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: APrevent Biotech GmbH

  • Matthias Leonhard, Dr, PRINCIPAL_INVESTIGATOR, Study principal investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-13
Study Completion Date2024-12

Study Record Updates

Study Start Date2019-11-13
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Paralysis, Unilateral, Vocal Cord