Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement

Phase

TERMINATED

Status

Enrollment

INDUSTRY

Sponsor class

Stopped The DMC terminated trial GLP\_2022C1P002 early, citing a no longer positive benefit risk ratio, very low recruitment (\<1 patient/year/site), no added patient risk, but no relevant advantages to justify continuing the study and potential risks of TIVA.

Conditions

Bilateral Vocal Cord Paralysis

Interventions

DEVICE: SPIRION Laryngeal Pacemaker System Implantation and follow-up

Sponsor

MED-EL Elektromedizinische Geräte GesmbH