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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implant called APrevent® VOIS-Implant for individuals with Unilateral Vocal Fold Paralysis (UVFP), which affects one vocal cord. The goal is to determine if the implant is safe and effective in improving voice issues. Individuals diagnosed with UVFP who experience voice problems that hinder daily communication might be suitable candidates. Participants must be willing to adhere to study requirements and attend all appointments. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatments for UVFP.

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 prior data suggests that the APrevent® VOIS-Implant is safe for treating Unilateral Vocal Fold Paralysis?

Research shows that the APrevent® VOIS-Implant addresses vocal cord problems, particularly unilateral vocal fold paralysis, where one vocal cord doesn't move. Earlier studies have tested this implant, and patients generally tolerate it well.

Past trials found no major safety issues. The implant's adjustability may help reduce potential side effects. Although specific side effects weren't detailed, its inclusion in this trial suggests a reasonable safety profile so far.

Overall, available evidence suggests the VOIS-Implant is safe for use. However, like any medical procedure, risks exist, so discussing concerns with the study team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for vocal cord paralysis, which often involve voice therapy or surgical interventions like thyroplasty, the APrevent® VOIS-Implant offers a unique approach by directly addressing the vocal cord paralysis with an implant. This implant is designed to improve vocal cord function by providing structural support, potentially leading to more immediate and lasting improvements in voice quality. Researchers are excited about this treatment because it could offer a less invasive and more durable solution compared to existing surgical options, giving patients better outcomes with potentially fewer complications.

What evidence suggests that the APrevent® VOIS-Implant is effective for Unilateral Vocal Fold Paralysis?

Research has shown that the APrevent® VOIS Implant, which participants in this trial will receive, offers promising results for treating Unilateral Vocal Fold Paralysis (UVFP). One study found that 87.5% of patients experienced much better glottal closure, crucial for enhancing voice quality. Another study demonstrated significant improvement in vocal efficiency, or how well the vocal cords function, after using the implant. Patients reported noticeable improvements in their voice, with better sound quality and control. These findings suggest that the VOIS Implant could effectively improve voice function in people with UVFP. ^{2 5 6 7 8}

Who Is on the Research Team?

Matthias Leonhard, Dr

Principal Investigator

Study principal investigator

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12503816/

Short-Term Evaluation of the APrevent® VOIS Implant Significant improvement in glottal closure was achieved in 28 patients (87.5%) 7 weeks after MT with VOIS implant. Adjustment via emptying and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10278099/

Pre‐clinical evaluation of APrevent® VOIS for unilateral ... 0046). Vocal efficiency increased significantly from 0.056 to 0.280 after implant insertion (p = .0167). For the fundamental frequency ...

3. withpower.com withpower.com/trial/phase-vocal-cord-paralysis-10-2019-fa114

APrevent® VOIS-Implant for Vocal Cord Paralysis The APrevent® VOIS implant demonstrated significant voice improvement in patients with unilateral vocal fold paralysis, with perceptual voice sound parameters ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20553551

APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non ... The purpose of this study is to assess the safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199724003357

Evaluating the Efficacy of Endoscopic Medialization ... Results. Eighteen patients completed the study. Significant improvements were observed in VHI scores at all postoperative time points (P < 0.001) ...

6. apreventmed.com apreventmed.com/datas/upload/site/ifu_en_20210818.pdf

APrevent® VOIS The VOIS implants are intended to be used for Type I Thyroplasty operations in patients with unilateral vocal fold paralysis (UVFP)/glottic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03864757

NCT03864757 | APrevent Vocal Implant System (VOIS) for ... Also called a data safety and monitoring board, or DSMB. ... APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis ( ...

8. cms.gov cms.gov/medicarecoverageideapproved-ide-studies/g200355-nct05119842

G200355-NCT05119842 Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open ...