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Functional Effect of Treatment of Glottic Insufficiency With Calcium Hydroxyapatite

NCT02275130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-04-05

No results posted yet for this study

Summary

The voice is an indispensable source of human communication. Current time puts high demands on the quality of voice in most professions. Organic or functional changes of vocal cords associated with their insufficiency lead to a deterioration of voice quality, voice fatigue, hoarseness or breathing difficulties. This has adverse psychological, social and economic consequences for the patient, the employer and its surroundings. The injection techniques can be performed under general and local anaesthesia. The defined injectable substance is inserted directly in the vocal cords, which increases its volume and results in an almost immediate improvement of the voice quality. For injection can be used various materials, e.g. autologous fat, calcium hydroxyapatite, silicone, and others. Injection techniques are less invasive, associated with less perioperative morbidity. Operation can be also performed under local anaesthesia in selected patients, therefore is preferred for patients with multiple comorbidities and risk of general anaesthesia.

Conditions

  • Glottic Insufficiency

Interventions

PROCEDURE

Calcium Hydroxyapatite

Surgical augmentation of the vocal cords with injection of calcium hydroxyapatite

DEVICE

Radiesse Voice (Calcium Hydroxyapatite)

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Radana Walderová, MD · University Hospital Ostrava

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02275130 on ClinicalTrials.gov