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

> **NCT06007144** · NA · TERMINATED · sponsor: **MED-EL Elektromedizinische Geräte GesmbH** · enrollment: 10 (actual)

## Conditions studied

- Bilateral Vocal Cord Paralysis

## Interventions

- **DEVICE:** SPIRION Laryngeal Pacemaker System Implantation and follow-up

## Key facts

- **NCT ID:** NCT06007144
- **Lead sponsor:** MED-EL Elektromedizinische Geräte GesmbH
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2023-08-18
- **Primary completion:** 2025-07-07
- **Final completion:** 2025-09-16
- **Target enrollment:** 10 (ACTUAL)
- **Why 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.
- **Last updated:** 2025-11-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06007144

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06007144, "Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT06007144. Licensed CC0.

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