Laryngo-pharyngeal RefluxNCT07696429
Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux
A study testing Lidocaine 10% Spray in people with Laryngo-pharyngeal Reflux, run by Mario Bilić at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to learn if topical anesthesia (lidocaine spray) affects the phonation process during High-Speed Digital Imaging (HSDI) laryngoscopy in adults with laryngopharyngeal reflux (LPR). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Laryngo-pharyngeal Reflux
- What is being tested?
- Lidocaine 10% Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Mar 2019to 5 Dec 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed laryngopharyngeal reflux (LPR), defined as Reflux Symptom Index (RSI) >13 and Reflux Finding Score (RFS) >7 Age 18-45 years No prior HSDI recording Ability to tolerate HSDI examination without topical anesthesia
Who cannot join
- Known allergy to lidocaine and/or other allergens Acute respiratory infection within the preceding month Current smokers or regular alcohol consumers Chronic rhinosinusitis Prior surgery and/or radiotherapy of the larynx, neck, or thyroid gland Inability to visualize the full length of the vocal folds during the 2-second HSDI recording for anatomical reasons
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Hospital Centre Zagreb (KBC Zagreb), Department of ORL Head and Neck Surgery
Zagreb, 10000
About this study
Official title: The Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux: A Randomized Double-Blind Placebo-Controlled Crossover Study
The goal of this clinical trial is to learn if topical anesthesia (lidocaine spray) affects the phonation process during High-Speed Digital Imaging (HSDI) laryngoscopy in adults with laryngopharyngeal reflux (LPR). The main questions it aims to answer are:
Does topical anesthesia change phonation process parameters (such as mucosal wave amplitude, glottal closure pattern, phase symmetry, and periodicity) as assessed on the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form? Does topical anesthesia change the type of glottal insufficiency observed during phonation?
Read more
Researchers will compare HSDI recordings performed with topical anesthesia (lidocaine spray) to recordings performed with placebo (physiological saline) to see if topical anesthesia alters phonation process findings.
Participants will:
Undergo HSDI laryngoscopy recording on two consecutive days, once with topical anesthesia and once with placebo, in a randomized, double-blind order Have a detailed medical history taken and complete the Reflux Symptom Index (RSI) questionnaire Undergo fiberendoscopic examination for determination of the Reflux Finding Score (RFS) Return for a follow-up examination within three months, during which they will continue proton pump inhibitor therapy and hygienic-dietary measures
Read the detailed description
Standard clinical practice for rigid transoral laryngoscopy, including High-Speed Digital Imaging (HSDI), includes the elective use of topical anesthesia of the oral cavity and oropharynx; however, clearly defined recommendations and indications for its use are lacking, and its potential effect on the phonation process has not been unequivocally established. Upon application to the oral cavity and oropharynx, anesthetic may drain into the larynx and desensitize the mucosa, potentially affecting sensorimotor aspects of laryngeal function. Existing studies on the effect of topical anesthesia on phonation during laryngoscopy are limited and report contradictory findings.
This prospective, randomized, double-blind, placebo-controlled crossover study assigned each participant a unique number via random number generator, determining the order of recording modalities (even numbers recorded first with topical anesthesia, odd numbers first without). Once assigned, the order could not be changed. Randomization and testing order were concealed from the examiner performing the HSDI recording.
Topical anesthesia (lidocaine spray, 100 mg/ml, 0.1 ml per actuation) or physiological saline (placebo) was applied by a junior physician, blinded to the substance used, to the base of the tongue, posterior pharyngeal wall, and soft palate (one actuation per site). HSDI recording was performed 5 minutes after application. Each participant underwent recording in both modalities on two consecutive days, a period considered sufficiently short to avoid confounding phonotraumatic, hormonal, or health-related changes.
HSDI recordings were performed by an experienced otorhinolaryngologist and phoniatrician (>5 years of experience) using a rigid 90° endoscope (Wolf 5562 HRES ENDOCAM with Wolf Auto LP 5132 Hlight light source, Richard Wolf GmbH, Knittlingen, Germany). Participants were seated upright with the tongue held protruded; the endoscope was passed along the midline of the tongue to visualize the full length of the vocal folds. Participants phonated the vowel /a/ dynamically and frequentially, and a 2-second HSDI recording was captured. Recordings were reviewed for quality (minimum 1,000 clear, focused, consecutive images of the full vocal fold length during the steady phonation phase); inadequate recordings were repeated. Fundamental frequency and phonation intensity were recorded via a microphone mounted on the endoscope with software processing. Maximum Phonation Time was determined from three stopwatch-timed measurements of sustained /a/ phonation, taken immediately before and after HSDI recording.
Each HSDI recording was independently assessed by two experienced otorhinolaryngologists/phoniatricians (>5 years of experience) using visual-perceptual analysis. Discrepancies in parameter scoring were resolved through joint re-analysis and discussion until consensus was reached before proceeding to the next recording. Assessment was standardized using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form and the European Laryngological Society (ELS) form for glottal closure pattern classification, along with a modified classification of glottal insufficiency. The Reflux Finding Score was re-determined from recordings according to the Belafsky et al. classification.
Participants underwent a follow-up examination within three months of study participation, during which the Reflux Finding Score (via fiberendoscopy) and Reflux Symptom Index (via questionnaire) were re-assessed while participants continued regular proton pump inhibitor therapy and hygienic-dietary measures; participants with persistent pathological findings were excluded from final analysis.
Statistical analysis included the Kolmogorov-Smirnov test for normality of distribution. Normally distributed variables were described using means and standard deviations; non-normally distributed variables were described using medians and ranges. Differences between recordings with and without topical anesthesia were tested using the paired t-test (parametric) or Wilcoxon signed-rank test (non-parametric), as appropriate. Spearman correlation and regression analysis were used to explore associations between anatomical structures and measured characteristics. A p-value <0.05 was considered statistically significant.
- Conditions
- Laryngo-pharyngeal Reflux
- Being tested
- Lidocaine 10% Spray, Placebo
- Keywords
- High-Speed Digital Imaging, Topical Anesthesia, Lidocaine, Laryngopharyngeal Reflux, Phonation
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 10% SprayDrug
Also called Xylocaine spray
Lidocaine spray, 100 mg/ml, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment.
PlaceboDrug
Also called Normal saline spray; 0.9% NaCl spray
Physiological saline (0.9% NaCl) spray, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment, identical in application technique to the lidocaine intervention.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia-First Sequence (A→B) | Experimental | Participants received topical anesthesia (lidocaine spray, 100 mg/ml) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received placebo (physiological saline), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization. Receives: Drug: Lidocaine 10% Spray; Drug: Placebo |
| Placebo-First Sequence (B→A) | Placebo comparator | Participants received placebo (physiological saline) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received topical anesthesia (lidocaine spray, 100 mg/ml), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization. Receives: Drug: Lidocaine 10% Spray; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Phonation Process Parameters Assessed by the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) Form
Parameters assessed by visual-perceptual analysis of HSDI recordings using the VALI form: glottal sufficiency pattern, mucosal wave amplitude, free edge amplitude, vertical level of the vocal folds, non-vibrating segment of the vocal fold, supraglottic structure activation, free edge contour, open-to-closed phase ratio of the glottal cycle, phase symmetry of the vocal folds, periodicity, and axis shift of the vocal folds. Each recording was independently scored by two blinded raters, with discrepancies resolved by consensus.
Measured: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Glottal Closure Pattern (European Laryngological Society Classification)
Glottal closure pattern during the initial phase of the glottal cycle, classified according to the European Laryngological Society (ELS) form (e.g., concave, convex, straight, complex), assessed by visual-perceptual analysis of HSDI recordings.
Measured: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Type of Glottal Insufficiency (European Laryngological Society Classification)
Type of glottal insufficiency during phonation, classified according to a modified European Laryngological Society (ELS) classification (e.g., complete glottal closure, incomplete closure in the cartilaginous part of the glottis), assessed by visual-perceptual analysis of HSDI recordings.
Measured: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Acoustic Voice Parameters (Fundamental Frequency and Phonation Intensity)
Fundamental frequency (F0, Hz) and phonation intensity (dB) during phonation of the sustained vowel /a/, recorded via a microphone mounted on the endoscope with software processing.
Measured: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Maximum Phonation Time (MPT)
Maximum duration (seconds) of sustained, dynamically stationary phonation of the vowel /a/ following maximal inhalation, determined as the longest of three stopwatch-timed trials performed immediately before and after HSDI recording.
Measured: Assessed immediately before and after each HSDI recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Mar 2019
- Primary completion5 Jan 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngo-pharyngeal RefluxStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-period, two-sequence crossover design. Each participant underwent HSDI laryngoscopy on two consecutive days, receiving topical anesthesia (lidocaine spray) on one day and placebo (physiological saline) on the other. Sequence order was determined by randomization (even-numbered participants: anesthesia first; odd-numbered: placebo first) and could not be altered once assigned.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Bilić
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Bilić, Clinical Hospital Centre Zagreb
- Investigators
- Mario Bilić, prof. dr. sc. dr. med., Principal investigator, Department of ORL Head and Neck Surgery, University Hospital Centre Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696429
- Sponsor's protocol ID
- Class No.8.1-19/31-2
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not made publicly available due to privacy and confidentiality restrictions related to patient health information. De-identified data underlying the results reported in this publication may be made available by the corresponding author upon reasonable request, subject to institutional and ethics committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux: A Randomized Double-Blind Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT07696429
- Acronym / sponsor ID
- Class No.8.1-19/31-2
- Conditions
- Laryngo-pharyngeal Reflux
- Keywords
- High-Speed Digital Imaging, Topical Anesthesia, Lidocaine, Laryngopharyngeal Reflux, Phonation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mario BilićUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 10 Jul 2026 (actual)
- 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 goal of this clinical trial is to learn if topical anesthesia (lidocaine spray) affects the phonation process during High-Speed Digital Imaging (HSDI) laryngoscopy in adults with laryngopharyngeal reflux (LPR). The main questions it aims to answer are:
Does topical anesthesia change phonation process parameters (such as mucosal wave amplitude, glottal closure pattern, phase symmetry, and periodicity) as assessed on the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form? Does topical anesthesia change the type of glottal insufficiency observed during phonation?
Researchers will compare HSDI recordings performed with topical anesthesia (lidocaine spray) to recordings performed with placebo (physiological saline) to see if topical anesthesia alters phonation process findings.
Participants will:
Undergo HSDI laryngoscopy recording on two consecutive days, once with topical anesthesia and once with placebo, in a randomized, double-blind order Have a detailed medical history taken and complete the Reflux Symptom Index (RSI) questionnaire Undergo fiberendoscopic examination for determination of the Reflux Finding Score (RFS) Return for a follow-up examination within three months, during which they will continue proton pump inhibitor therapy and hygienic-dietary measures
Detailed description
Standard clinical practice for rigid transoral laryngoscopy, including High-Speed Digital Imaging (HSDI), includes the elective use of topical anesthesia of the oral cavity and oropharynx; however, clearly defined recommendations and indications for its use are lacking, and its potential effect on the phonation process has not been unequivocally established. Upon application to the oral cavity and oropharynx, anesthetic may drain into the larynx and desensitize the mucosa, potentially affecting sensorimotor aspects of laryngeal function. Existing studies on the effect of topical anesthesia on phonation during laryngoscopy are limited and report contradictory findings.
This prospective, randomized, double-blind, placebo-controlled crossover study assigned each participant a unique number via random number generator, determining the order of recording modalities (even numbers recorded first with topical anesthesia, odd numbers first without). Once assigned, the order could not be changed. Randomization and testing order were concealed from the examiner performing the HSDI recording.
Topical anesthesia (lidocaine spray, 100 mg/ml, 0.1 ml per actuation) or physiological saline (placebo) was applied by a junior physician, blinded to the substance used, to the base of the tongue, posterior pharyngeal wall, and soft palate (one actuation per site). HSDI recording was performed 5 minutes after application. Each participant underwent recording in both modalities on two consecutive days, a period considered sufficiently short to avoid confounding phonotraumatic, hormonal, or health-related changes.
HSDI recordings were performed by an experienced otorhinolaryngologist and phoniatrician (>5 years of experience) using a rigid 90° endoscope (Wolf 5562 HRES ENDOCAM with Wolf Auto LP 5132 Hlight light source, Richard Wolf GmbH, Knittlingen, Germany). Participants were seated upright with the tongue held protruded; the endoscope was passed along the midline of the tongue to visualize the full length of the vocal folds. Participants phonated the vowel /a/ dynamically and frequentially, and a 2-second HSDI recording was captured. Recordings were reviewed for quality (minimum 1,000 clear, focused, consecutive images of the full vocal fold length during the steady phonation phase); inadequate recordings were repeated. Fundamental frequency and phonation intensity were recorded via a microphone mounted on the endoscope with software processing. Maximum Phonation Time was determined from three stopwatch-timed measurements of sustained /a/ phonation, taken immediately before and after HSDI recording.
Each HSDI recording was independently assessed by two experienced otorhinolaryngologists/phoniatricians (>5 years of experience) using visual-perceptual analysis. Discrepancies in parameter scoring were resolved through joint re-analysis and discussion until consensus was reached before proceeding to the next recording. Assessment was standardized using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form and the European Laryngological Society (ELS) form for glottal closure pattern classification, along with a modified classification of glottal insufficiency. The Reflux Finding Score was re-determined from recordings according to the Belafsky et al. classification.
Participants underwent a follow-up examination within three months of study participation, during which the Reflux Finding Score (via fiberendoscopy) and Reflux Symptom Index (via questionnaire) were re-assessed while participants continued regular proton pump inhibitor therapy and hygienic-dietary measures; participants with persistent pathological findings were excluded from final analysis.
Statistical analysis included the Kolmogorov-Smirnov test for normality of distribution. Normally distributed variables were described using means and standard deviations; non-normally distributed variables were described using medians and ranges. Differences between recordings with and without topical anesthesia were tested using the paired t-test (parametric) or Wilcoxon signed-rank test (non-parametric), as appropriate. Spearman correlation and regression analysis were used to explore associations between anatomical structures and measured characteristics. A p-value <0.05 was considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-period, two-sequence crossover design. Each participant underwent HSDI laryngoscopy on two consecutive days, receiving topical anesthesia (lidocaine spray) on one day and placebo (physiological saline) on the other. Sequence order was determined by randomization (even-numbered participants: anesthesia first; odd-numbered: placebo first) and could not be altered once assigned.
| Arm | Type | Receives |
|---|---|---|
| Anesthesia-First Sequence (A→B) | Experimental | Drug: Lidocaine 10% Spray, Drug: PlaceboParticipants received topical anesthesia (lidocaine spray, 100 mg/ml) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received placebo (physiological saline), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization. |
| Placebo-First Sequence (B→A) | Placebo comparator | Drug: Lidocaine 10% Spray, Drug: PlaceboParticipants received placebo (physiological saline) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received topical anesthesia (lidocaine spray, 100 mg/ml), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Newly diagnosed laryngopharyngeal reflux (LPR), defined as Reflux Symptom Index (RSI) >13 and Reflux Finding Score (RFS) >7 Age 18-45 years No prior HSDI recording Ability to tolerate HSDI examination without topical anesthesia
Key exclusion criteria (1 listed)
- Known allergy to lidocaine and/or other allergens Acute respiratory infection within the preceding month Current smokers or regular alcohol consumers Chronic rhinosinusitis Prior surgery and/or radiotherapy of the larynx, neck, or thyroid gland Inability to visualize the full length of the vocal folds during the 2-second HSDI recording for anatomical reasons
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 |
|---|---|---|
| Lidocaine 10% SprayAlso: Xylocaine sprayLidocaine spray, 100 mg/ml, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment. | Drug | Anesthesia-First Sequence (A→B), Placebo-First Sequence (B→A) |
| PlaceboAlso: Normal saline spray; 0.9% NaCl sprayPhysiological saline (0.9% NaCl) spray, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment, identical in application technique to the lidocaine intervention. | Drug | Anesthesia-First Sequence (A→B), Placebo-First Sequence (B→A) |
Primary outcome
Change in Phonation Process Parameters Assessed by the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) Form
Time frame: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Parameters assessed by visual-perceptual analysis of HSDI recordings using the VALI form: glottal sufficiency pattern, mucosal wave amplitude, free edge amplitude, vertical level of the vocal folds, non-vibrating segment of the vocal fold, supraglottic structure activation, free edge contour, open-to-closed phase ratio of the glottal cycle, phase symmetry of the vocal folds, periodicity, and axis shift of the vocal folds. Each recording was independently scored by two blinded raters, with discrepancies resolved by consensus.
Change in Glottal Closure Pattern (European Laryngological Society Classification)
Time frame: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Glottal closure pattern during the initial phase of the glottal cycle, classified according to the European Laryngological Society (ELS) form (e.g., concave, convex, straight, complex), assessed by visual-perceptual analysis of HSDI recordings.
Change in Type of Glottal Insufficiency (European Laryngological Society Classification)
Time frame: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Type of glottal insufficiency during phonation, classified according to a modified European Laryngological Society (ELS) classification (e.g., complete glottal closure, incomplete closure in the cartilaginous part of the glottis), assessed by visual-perceptual analysis of HSDI recordings.
Change in Acoustic Voice Parameters (Fundamental Frequency and Phonation Intensity)
Time frame: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Fundamental frequency (F0, Hz) and phonation intensity (dB) during phonation of the sustained vowel /a/, recorded via a microphone mounted on the endoscope with software processing.
Change in Maximum Phonation Time (MPT)
Time frame: Assessed immediately before and after each HSDI recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Maximum duration (seconds) of sustained, dynamically stationary phonation of the vowel /a/ following maximal inhalation, determined as the longest of three stopwatch-timed trials performed immediately before and after HSDI recording.
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 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data are not made publicly available due to privacy and confidentiality restrictions related to patient health information. De-identified data underlying the results reported in this publication may be made available by the corresponding author upon reasonable request, subject to institutional and ethics committee approval.
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European TIF2.0 Registry
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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.
Mario Bilić, prof. dr. sc. dr. med. principal investigator
Department of ORL Head and Neck Surgery, University Hospital Centre Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 10% Spray in people with Laryngo-pharyngeal Reflux, run by Mario Bilić at 1 site in Croatia.
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 1 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 10 Jul 2026. 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 Croatia. 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. Some participants in this study may receive a placebo. 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?
Change in Phonation Process Parameters Assessed by the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) Form (time frame: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)). The study lists 5 primary outcomes in all. 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 10 Jul 2026.