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Volume and position change of Gore-Tex® after bilateral medialization thyroplasty assessed by MRI

Volume and position change of Gore-Tex® after bilateral medialization thyroplasty assessed by MRI - Volume and position change of Gore-Tex® after medialization thyroplasty

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54926
Enrollment
10
Registered
2020-01-17
Start date
2021-09-24
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

glottic insufficiency voice disorder

Interventions

&nbsp
2 MRI-scans (without contrast)&nbsp

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria:  - Adult >18 years old - Glottic insufficiency caused by vocal fold atrophy with or without sulcus - Consented for bilateral medialization thyroplasty with Gore-Tex® under local  anaesthesia - No contraindication for MRI - To be able and willing of giving informed consent 

Exclusion criteria

Exclusion criteria:  - Patients undergoing unilateral medialization thyroplasty - Patients with medical history of phonosurgery  - Patients with revision thyroplasty - Patients with medical history of head and neck malignancy - Patients with other causes of glottic insufficiency (paralysis, hypomobility,  paresis, vocal fold scar) - Patients not fit for bilateral medialization thyroplasty under local  anesthesia - Patients not able to undergo MRI scanning, e.g. metal implants,  claustrophobia 

Design outcomes

Primary

MeasureTime frame
Change in implanted Gore-Tex® in volume and position.

Secondary

MeasureTime frame
voice parameters: VHI-30 questionnair, maximum phonation time (MPT), dynamic range, fundamental frequency (F0), melodic range.

Countries

Netherlands

Contacts

Public ContactB.M. Verbist

Leids Universitair Medisch Centrum

kno-onderzoek@lumc.nl071-5262408

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)