Functional Effect of Treatment of Glottic Insufficiency With Calcium Hydroxyapatite
Assessment of the Functional Effect of Treatment of Glottic Insufficiency With Injection Technique With the Use of Calcium Hydroxyapatite
2 other identifiers
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedApril 5, 2018
April 1, 2018
3.7 years
October 15, 2014
April 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective improvement of voice parameters
irregularity, noise, overall severity, jitter, shimmer, GNE
32 months
Secondary Outcomes (1)
Endoscopic assessment
32 months
Study Arms (1)
Calcium Hydroxyapatite
EXPERIMENTAL30 patients with glottic insufficiency treated operatively with augmentation of vocal cords with injection technique
Interventions
Surgical augmentation of the vocal cords with injection of calcium hydroxyapatite
Eligibility Criteria
You may qualify if:
- Age 18-70 years
- Insufficiency caused by paresis or atrophy
- Duration of insufficiency of at least six months
- Size of the insufficiency not exceeding three millimetres
- Signing of the informed consent
You may not qualify if:
- Size of the insufficiency exceeding three millimetres
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ostrava
Ostrava, Czech Republic, 708 52, Czechia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Radana Walderová, MD
University Hospital Ostrava
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 27, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
April 5, 2018
Record last verified: 2018-04