APrevent® VOIS-Implant for Vocal Cord Paralysis

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Matthias Leonhard, Dr

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: APrevent Biotech GmbH

Disqualifiers: Bilateral vocal fold paralysis, Severe OSA, Diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to understand any specific requirements.

What data supports the effectiveness of the APrevent® VOIS-Implant treatment for vocal cord paralysis?

The APrevent® VOIS-Implant has shown promising results in improving voice quality for patients with unilateral vocal fold paralysis, as it allows for postoperative adjustments to enhance outcomes. Studies have demonstrated its effectiveness in both short-term and long-term voice improvements, making it a flexible and innovative option for treating this condition. ^{1 2 3 4 5}

How is the APrevent® VOIS-Implant treatment different from other treatments for vocal cord paralysis?

The APrevent® VOIS-Implant is unique because it is an adjustable implant used in medialization thyroplasty (a surgical procedure to improve voice by repositioning the vocal cords) for vocal cord paralysis. Unlike previous implants, it allows for postoperative adjustments, which can help avoid additional surgeries if further modifications are needed. ^{1 2 3 4 5}

Research Team

Matthias Leonhard, Dr

Principal Investigator

Study principal investigator

Eligibility Criteria

This trial is for men and women aged 18-80 with permanent Unilateral Vocal Fold Paralysis (UVFP) causing significant voice issues. Participants must be able to follow the study plan, attend all sessions, and understand the risks. Exclusions include those with tracheostomy, recent laryngeal procedures, vocal fold lesions, severe infections or sleep apnea, tumors in throat areas, total cordectomy, severe speech disorders unrelated to UVFP.

Inclusion Criteria

I am between 18 and 80 years old.

I have been diagnosed with permanent vocal fold paralysis and my vocal folds don't close properly.

I can follow the study's requirements and work with the research team.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant.

I have been diagnosed with severe obstructive sleep apnea.

I have a tumor in my throat or voice box.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the APrevent® VOIS Implant during a type I thyroplasty

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person) at Week 1, Week 7, Month 6, and Month 12

Part A - Safety Assessment

Initial safety assessment of the implant in 8 patients

7 weeks

Part B - Effectiveness Assessment

Assessment of the performance (effectiveness) of the investigational device

7 weeks

Treatment Details

Interventions

• APrevent® VOIS-Implant (Implant)

Trial Overview The APrevent® VOIS Implant is being tested for safety and effectiveness in treating UVFP. The trial involves 30 patients across multiple centers who will receive this open-label treatment without randomization—meaning everyone gets the implant—and their progress will be closely monitored.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Treatment with the VOIS Implant

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic - Phoenix Phoenix, AZ

Greater Baltimore Medical Center Baltimore, MD

The University of Texas Health Science Center at Houston Houston, TX

Cleveland Clinic Cleveland, OH

Who Is Running the Clinical Trial?

APrevent Biotech GmbH

Lead Sponsor

Trials

2

Patients Recruited

40+

References

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcomes of VOIS-Implant in Patients With Unilateral Vocal Fold Paralysis. [2022] Evaluation of the clinical outcomes after 6 months of treatment with a novel adjustable implant, the APrevent® Vocal-Implant-System (VOIS), in conjunction with medialization thyroplasty (MT) in patients with unilateral vocal fold paralysis.

2. Germany pubmed.ncbi.nlm.nih.gov

Pre- and intraoperative acoustic and functional assessment of the novel APrevent® VOIS implant during routine medialization thyroplasty. [2021] Label="PURPOSE" NlmCategory="OBJECTIVE">Persistent unilateral vocal fold paralysis (UFVP) with glottal insufficiency often requires type I medialization thyroplasty (MT). Previous implants cannot be adjusted postoperatively if necessary. The newly developed APrevent® VOIS implant (VOIS) can provide postoperative re-adjustment to avoid revision MT. The objective of this pilot study is to evaluate the VOIS intraoperatively concerning voice improvement, surgical feasibility and device handling.

3. Germany pubmed.ncbi.nlm.nih.gov

Long-term voice outcomes of medialization thyroplasty with adjustable implant for unilateral vocal fold paralysis. [2023] Label="OBJECTIVES" NlmCategory="OBJECTIVE">Medialization thyroplasty (MT) using various implants has been employed as a corrective procedure for unilateral vocal fold paralysis (UVFP). A newly developed APrevent® vocal implant system (VOIS) offers an innovative solution with a finely adjustable design. This study aimed to investigate the long-term functional voice outcomes and benefits of postoperative adjustments in patients receiving MT using the VOIS-implant.

4. United States pubmed.ncbi.nlm.nih.gov

Pre-clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization. [2023] To evaluate the concept and efficacy of an adjustable implant (Prototype SH30: porcine implant and APrevent® VOIS: human concept) for treatment of unilateral vocal fold paralysis (UVFP) via in vivo mini-pig studies, human computed tomographic (CT) and magnetic resonance (MR) image analysis, ex-vivo aerodynamic and acoustic analysis.

5. Germany pubmed.ncbi.nlm.nih.gov

[Quality of voice and life after injectionlaryngoplasty using VOX Implants(®) (polydimethylsiloxane)]. [2014] Within the last years the injection laryngoplasty is a common method in treating patients with a unilateral vocal cord paralysis. The augmentation with VOX-Implants is an option for a permanent treatment. The aim was to evaluate the quality of voice as well as the quality of life in this patients and especially if it is comparable to other methods.