APrevent® VOIS-Implant for Vocal Cord Paralysis

Recruiting at 6 trial locations

Overseen By Berit Schneider-Stickler, Prof

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: APrevent Biotech GmbH

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Immediate

30 Participants Needed

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 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.

I understand the study's purpose, risks, and side effects.

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.

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

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

Who Is Running the Clinical Trial?

APrevent Biotech GmbH

Lead Sponsor

Trials

2

Recruited

40+

Findings from Research

The APrevent® Vocal-Implant-System (VOIS) combined with medialization thyroplasty significantly improved voice quality and glottal efficiency in 13 patients with unilateral vocal fold paralysis, with notable enhancements in maximum phonation time and voice handicap index after 6 months.

The procedure was safe, with no complications reported, and allowed for postoperative adjustments to further optimize voice quality and glottal closure, demonstrating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcomes of VOIS-Implant in Patients With Unilateral Vocal Fold Paralysis. Hsieh, LC., Chen, CK., Chang, CW., et al.[2022]

The APrevent® VOIS implant demonstrated significant voice improvement in patients with unilateral vocal fold paralysis, with perceptual voice sound parameters showing marked enhancement after implantation, similar to the traditional Titanium Vocal Fold Medialization Implant (TVFMI™).

Surgical feasibility and handling of the VOIS implant were rated as satisfactory by the surgeon, indicating that it can be safely integrated into routine procedures without adverse events, while also allowing for potential postoperative adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre- and intraoperative acoustic and functional assessment of the novel APrevent® VOIS implant during routine medialization thyroplasty. Ho, GY., Leonhard, M., Denk-Linnert, DM., et al.[2021]

Medialization thyroplasty using the APrevent® vocal implant system significantly improved voice quality in 14 patients with unilateral vocal fold paralysis, with stable results maintained for over a year.

The ability to make postoperative adjustments to the implant led to immediate improvements in voice quality, demonstrating the system's effectiveness without the need for major revision surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term voice outcomes of medialization thyroplasty with adjustable implant for unilateral vocal fold paralysis. Huang, PK., Chen, CK., Yu, YH., et al.[2023]

The adjustable implant prototype significantly improved glottic closure in a porcine model of unilateral vocal fold paralysis, with most subjects achieving complete closure, indicating its potential efficacy for treating this condition.

CT and MR imaging successfully identified the correct implant size in 97.3% of cases, which is crucial for standardizing the procedure and ensuring effective treatment in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization. Ho, GM., Rast, J., Hsieh, LC., et al.[2023]

In a study of 20 patients with unilateral vocal cord paralysis, injection laryngoplasty using VOX-Implants significantly improved voice quality, as shown by a decrease in the Voice Handicap Index (VHI-12) from 30.4 to 13.6 points and an increase in maximum phonation time from 6.45 seconds to 13.95 seconds post-surgery.

The procedure demonstrated no complications related to the VOX-Implants within a 6-month follow-up, indicating a safe and effective option for improving voice quality and quality of life, comparable to other methods like Thyroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of voice and life after injectionlaryngoplasty using VOX Implants(®) (polydimethylsiloxane)]. Koelmel, JC., Sittel, C.[2014]

References

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

Preliminary Clinical Outcomes of VOIS-Implant in Patients With Unilateral Vocal Fold Paralysis. [2022]

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]

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

Long-term voice outcomes of medialization thyroplasty with adjustable implant for unilateral vocal fold paralysis. [2023]

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

Pre-clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization. [2023]

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

[Quality of voice and life after injectionlaryngoplasty using VOX Implants(®) (polydimethylsiloxane)]. [2014]