Randomized, exploratory comparative study to investigate the effect of two different vocal fold augmentation materials on voice quality in unilateral vocal fold paresis.

Randomized, exploratory comparative study to investigate the effect of two different vocal fold augmentation materials on voice quality in unilateral vocal fold paresis. - STIMMAUGMENT

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024026

Enrollment

Registered

2021-02-01

Start date

2022-10-18

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J38.01

Interventions

Group 1: Vocal fold augmentation with autologous fat (n=12) Preoperative: Stroboscopy VHI-30 RBH Objective voice parameters Quality of live assessment (WHOQOL-BREF) Surgery: Vocal fold augmentation

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 80 years with symptomatic unilateral vocal fold paresis without sufficient improvement under conservative therapy for more than six months, in whom in principle both methods of vocal fold augmentation (autologous fat or aquamide) can be used, are eligible for inclusion.

Exclusion criteria

Exclusion criteria: - Incorrect or incomplete documentation - Previous laryngeal surgery with the exception of previous augmentation with absorbable material (hyaluron) - Laryngeal carcinoma - Pulmonary diseases

Design outcomes

Primary

Measure	Time frame
Change in subjective self-assessment of voice, 3,6 and 12 months after surgery, by questionnaire (VHI-30).	—

Secondary

Measure	Time frame
Postoperative change in external evaluation of voice quality (HIRANO-score) over time.	—

Countries

Germany

Contacts

Public ContactKevin Hansen

Universitätsklinikum Köln

kevin.hansen@uk-koeln.de0221 478 78970

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026