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

APrevent Biotech GmbH · NCT05119842

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
3
Study start
November 13, 2019
Record last updated
February 6, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: APrevent® VOIS-Implant

Conditions: Paralysis, Unilateral, Vocal Cord

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Mayo Clinic - Phoenix

    Phoenix, AZ 85054

    Site contact: Clinical Research Coordinator, RN · 480-574-1792 · Poletti.Samantha@mayo.edu

  • Greater Baltimore Medical Center

    Baltimore, MD 21204

    Site contact: Clinical Coordinator, Senior Speech-Language Pathologist, MM, MS, CCC-SLP · (443) 849-2087 · MBIDLACK@gbmc.org

  • The University of Texas Health Science Center at Houston

    Houston, TX 77030

    Site contact: Research Coordinator · 713.704.4137 · Candace.Hernandez@uth.tmc.edu

Study contacts (from the official record)

  • Berit Schneider-Stickler, Prof · + 43-676-842 311 311 · office@med4com.at
  • Matthias Leonhard, Dr · +43 1 404 00 - 33170 · matthias.leonhard@meduniwien.ac.at
All healthy volunteers studies in Arizona →
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized… (NCT05119842) | Bored Studies