The clinical trial of “The CHAEUM Premium NO.2” to Evaluate the Temporary Efficacy and Safety for Injection Laryngoplasty in Unilateral Vocal Fold Palsy

The Investigation of “The CHAEUM Premium NO.2” to Evaluate the Temporary Efficacy and Safety for Injection Laryngoplasty in Unilateral Vocal Fold Palsy – A single center, single group, single administration, single blind (assessor), and prospective investigator initiated exploratory clinical trial for medical device

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0007597

Enrollment

Registered

2022-08-03

Start date

2022-09-01

Completion date

Unknown

Last updated

2022-09-20

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

Conditions

None listed

Interventions

Medical Device : Single injection laryngoplasty to the paralyzed vocal cord using hyaluronic acid filler "The CHAEUM Premium NO.2" (Trans-cricothyroid membrane approach)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Unilateral vocal cord paralysis patients with hoarseness or aspiration who are required for injection laryngoplasty, regardless of the occurence time and severity

Exclusion criteria

Exclusion criteria: 1) Patients with coagulopathy 2) Immunocompromised patients

Design outcomes

Primary

Measure	Time frame
Auditory-perceptual evaluation (GRBAS scale) before and after injection laryngoplasty	—

Secondary

Measure	Time frame
Voice Handicap Index (VHI-10) before and after injection laryngoplasty	—

Countries

Korea, Republic of

Contacts

Public ContactMin-Su Kim

CHA University

abraxas8109@hanmail.net+82-31-780-4864

Outcome results