Glottic InsufficiencyNCT02275130
Functional Effect of Treatment of Glottic Insufficiency With Calcium Hydroxyapatite
A study testing Calcium Hydroxyapatite and Radiesse Voice (Calcium Hydroxyapatite) in people with Glottic Insufficiency, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glottic Insufficiency
- What is being tested?
- Calcium Hydroxyapatite and Radiesse Voice (Calcium Hydroxyapatite)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Size of the insufficiency exceeding three millimetres
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Functional Effect of Treatment of Glottic Insufficiency With Injection Technique With the Use of Calcium Hydroxyapatite
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.
Read the detailed description
The causes of glottic insufficiency (vocal fold insufficiency) may be paresis (immobility) of one or both vocal folds (of iatrogenic aetiology after thyroid surgery, neck operations or ingrowth of malignant tumours of the chest or mediastinum, idiopathic after viral infections or central neuropathy) and atrophy (loss of mass) of the vocal cords, which particularly affect older patients. Surgical treatment of insufficiency is indicated for patients in whom conservative treatment is ineffective.
Surgical treatment of vocal fold insufficiency is carried out in two ways:
- By thyroplasty type I, operations performed mostly under general anaesthesia, by the external access to the neck with the insertion of a silicone block through the thyroid cartilage into the space next to the vocal cords, which moves it medially.
- Augmentation of the vocal cords, at which an insertion of an own (fat, cartilage, etc.) or a foreign (Gore-Tex, silicone, etc.) material laterally from the vocal cords can facilitate a change in the position of the vocal cords. In recent years, more and more so-called augmentation injection techniques are preferred.
While thyroplasty has been carried out in the Czech Republic for 10-15 years, the clinicians have had only limited experience with the injection techniques, which has been used for several years only and information about the functional results are still insufficient to date.
The working hypotheses
- Augmentation of vocal folds with hydroxyapatite leads to significant improvements in subjective and objective parameters of voice
- Augmentation of vocal folds with hydroxyapatite is a method comparable with other methods of treatment of glottic insufficiency (thyroplasty type 1, vocal folds augmentation with autologous fat)
- Augmentation of vocal folds with hydroxyapatite can be performed under local anaesthesia The objective of the study is to determine the functional effect of augmented vocal folds with calcium hydroxyapatite ("Radiesse Voice") by comparing selected defined parameters preoperatively and postoperatively.
Other anticipated benefits of the study treatment include improving the quality of life of patients (improved voice quality, breathing, improve of mental state, preventing of social isolation and economic consequences). It will also lead to the introduction of new processes, materials and methods. It is also possible to expect shortening of the hospital stay, decrease in postoperative morbidity, and the possibility to perform the procedure on an outpatient basis.
The study has been designed as a prospective study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and has been approved by the Ethical Committee of the University Hospital Ostrava.
The patients enrolled in the study will be followed for the period of twelve months.
Timetable of the study procedures and controls:
Preoperative examination:
- Demographic data on age, sex, weight, height, smoking, cause of insufficiency
- Questionnaires Voice Handicap Index (VHI)
- Stroboscopy examination (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range
Examination 3 months postoperatively
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range
Examination 6 months after surgery
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range.
Examination 12 months after surgery (optional examination with cooperative patients)
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range.
Statistical data processing For statistical evaluation descriptive statistics will be used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests will be evaluated at the significance level of 5%. Statistical analysis will be performed in the "Stata 10" programme. Program MS Excel will be used for data collection.
- Conditions
- Glottic Insufficiency
- Being tested
- Calcium Hydroxyapatite, Radiesse Voice (Calcium Hydroxyapatite)
- Keywords
- glottic insufficiency, calcium hydroxyapatite, augmentation of vocal cords with injection technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium HydroxyapatiteProcedure or surgery
Also called Radiesse Voice
Surgical augmentation of the vocal cords with injection of calcium hydroxyapatite
Radiesse Voice (Calcium Hydroxyapatite)Device
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxyapatite | Experimental | 30 patients with glottic insufficiency treated operatively with augmentation of vocal cords with injection technique Receives: Procedure: Calcium Hydroxyapatite; Device: Radiesse Voice (Calcium Hydroxyapatite) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective improvement of voice parameters
irregularity, noise, overall severity, jitter, shimmer, GNE
Measured: 32 months
Secondary outcomes (1)
Endoscopic assessment
The presence or absence of insufficiency (YES/NO) will be assessed prior to the surgical intervention and after the intervention, by the means of endoscopy examination
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glottic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radana Walderová, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275130
- Sponsor's protocol ID
- FNO-ENT-Radiesse Voice
- Other IDs
- DRO-FNOs/2014
- Status last verified
- Apr 2018
- First submitted
- 15 Oct 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Functional Effect of Treatment of Glottic Insufficiency With Injection Technique With the Use of Calcium Hydroxyapatite
- ClinicalTrials.gov ID
- NCT02275130
- Acronym / sponsor ID
- FNO-ENT-Radiesse Voice
- Conditions
- Glottic Insufficiency
- Keywords
- glottic insufficiency, calcium hydroxyapatite, augmentation of vocal cords with injection technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The causes of glottic insufficiency (vocal fold insufficiency) may be paresis (immobility) of one or both vocal folds (of iatrogenic aetiology after thyroid surgery, neck operations or ingrowth of malignant tumours of the chest or mediastinum, idiopathic after viral infections or central neuropathy) and atrophy (loss of mass) of the vocal cords, which particularly affect older patients. Surgical treatment of insufficiency is indicated for patients in whom conservative treatment is ineffective.
Surgical treatment of vocal fold insufficiency is carried out in two ways:
- By thyroplasty type I, operations performed mostly under general anaesthesia, by the external access to the neck with the insertion of a silicone block through the thyroid cartilage into the space next to the vocal cords, which moves it medially.
- Augmentation of the vocal cords, at which an insertion of an own (fat, cartilage, etc.) or a foreign (Gore-Tex, silicone, etc.) material laterally from the vocal cords can facilitate a change in the position of the vocal cords. In recent years, more and more so-called augmentation injection techniques are preferred.
While thyroplasty has been carried out in the Czech Republic for 10-15 years, the clinicians have had only limited experience with the injection techniques, which has been used for several years only and information about the functional results are still insufficient to date.
The working hypotheses
- Augmentation of vocal folds with hydroxyapatite leads to significant improvements in subjective and objective parameters of voice
- Augmentation of vocal folds with hydroxyapatite is a method comparable with other methods of treatment of glottic insufficiency (thyroplasty type 1, vocal folds augmentation with autologous fat)
- Augmentation of vocal folds with hydroxyapatite can be performed under local anaesthesia The objective of the study is to determine the functional effect of augmented vocal folds with calcium hydroxyapatite ("Radiesse Voice") by comparing selected defined parameters preoperatively and postoperatively.
Other anticipated benefits of the study treatment include improving the quality of life of patients (improved voice quality, breathing, improve of mental state, preventing of social isolation and economic consequences). It will also lead to the introduction of new processes, materials and methods. It is also possible to expect shortening of the hospital stay, decrease in postoperative morbidity, and the possibility to perform the procedure on an outpatient basis.
The study has been designed as a prospective study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and has been approved by the Ethical Committee of the University Hospital Ostrava.
The patients enrolled in the study will be followed for the period of twelve months.
Timetable of the study procedures and controls:
Preoperative examination:
- Demographic data on age, sex, weight, height, smoking, cause of insufficiency
- Questionnaires Voice Handicap Index (VHI)
- Stroboscopy examination (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range
Examination 3 months postoperatively
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range
Examination 6 months after surgery
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range.
Examination 12 months after surgery (optional examination with cooperative patients)
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia, Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice range.
Statistical data processing For statistical evaluation descriptive statistics will be used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests will be evaluated at the significance level of 5%. Statistical analysis will be performed in the "Stata 10" programme. Program MS Excel will be used for data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxyapatite | Experimental | Procedure: Calcium Hydroxyapatite, Device: Radiesse Voice (Calcium Hydroxyapatite)30 patients with glottic insufficiency treated operatively with augmentation of vocal cords with injection technique |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Size of the insufficiency exceeding three millimetres
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium HydroxyapatiteAlso: Radiesse VoiceSurgical augmentation of the vocal cords with injection of calcium hydroxyapatite | Procedure or surgery | Calcium Hydroxyapatite |
| Radiesse Voice (Calcium Hydroxyapatite) | Device | Calcium Hydroxyapatite |
Primary outcome
Objective improvement of voice parameters
Time frame: 32 months
irregularity, noise, overall severity, jitter, shimmer, GNE
1 secondary outcome
Endoscopic assessment
Time frame: 32 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radana Walderová, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxyapatite and Radiesse Voice (Calcium Hydroxyapatite) in people with Glottic Insufficiency, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective improvement of voice parameters (time frame: 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.