Recruiting

Observational Study

Sponsor:

APrevent Biotech GmbH

Code:

NCT05119842

Conditions

Paralysis, Unilateral, Vocal Cord

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

APrevent® VOIS-Implant

Study Details

Brief summary:

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.

Conditions

Paralysis, Unilateral, Vocal Cord

Study ID

NCT05119842

Start date

Nov 13, 2019

Status verified date

Feb, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male and female patients between 18 and 80 years
  • Diagnosed with permanent UVFP and insufficient glottal closure
  • A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-30 score >33)
  • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
  • Ability to co-operate with the Investigator and to comply with the requirements of the entire study
  • 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

Exclusion Criteria:

  • 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
  • Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
  • Bilateral vocal fold paralysis
  • 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.
  • Presence of structural vocal fold lesions such as polyp or nodules
  • Presence of oropharyngeal or laryngeal tumors
  • Patients with diagnosed severe obstructive sleep apnea (OSA)
  • Status post total cordectomy
  • Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
  • Status post tracheostomy
  • Presence of acute systemic infection at time of screening or shortly before surgery
  • Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
  • Severe coagulopathy
  • Females who are pregnant, lactating or planning pregnancy are excluded from the investigation
  • Patients with bil. Gr. III-IV hypertrophic tonsils
  • Diabetes mellitus with poor control and poor wound healing history

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Treatment with the VOIS Implant

Interventions

APrevent® VOIS-Implant

To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.

Primary outcome measure

  • Change in G-Score from GRBAS-Scale [ Time Frame: 7weeks ]

Central Contacts and Locations

Central contacts

Berit Schneider-Stickler, Prof

+ 43-676-842 311 311office@med4com.at

Matthias Leonhard, Dr

+43 1 404 00 - 33170matthias.leonhard@meduniwien.ac.at

Locations

Mayo Clinic - Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Research Coordinator, RN

480-574-1792Poletti.Samantha@mayo.edu

Principal Investigator:

David Lott, MD

Greater Baltimore Medical Center

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Clinical Coordinator, Senior Speech-Language Pathologist, MM, MS, CCC-SLP

(443) 849-2087MBIDLACK@gbmc.org

Principal Investigator:

Lee Akst, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Research Coordinator

713.704.4137Candace.Hernandez@uth.tmc.edu

Principal Investigator:

Andrew Tritter, MD

More Information

Sponsor

APrevent Biotech GmbH

Last update posted

Feb 6, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by APrevent Biotech GmbH on 2025-02-06.