Sore-throatNo-PILSNCT05383417
No Post Intubation Laryngeal Symptoms
A study testing EndoClip in people with Sore-throat and Dysphonia, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sore-throat, Dysphonia, Dysphagia
- What is being tested?
- EndoClip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing general endotracheal anesthesia with an endotracheal tube
- Patient is not undergoing a procedure in the head and neck region
Who cannot join
- Patient with pre-existing severe sore throat, voice change, or trouble swallowing
- Patient undergoing surgery in the head and neck region
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Health
La Jolla, California, 92037-7895
About this study
Official title: Endotracheal Tube Clip for Prevention of Post Intubation Laryngeal Symptoms
The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing.
Read the detailed description
Single center randomized controlled trial with 100 subjects who will be intubated for already planned surgeries. The participants will be randomized into the control group or the clip group. The clip group will have a small clip (the endotracheal tube support device) placed on the endotracheal tube to reduce the pressure on the vocal cords and larynx. This endotracheal tube support device is made from a FDA approved biocompatible material.
The control group subjects will undergo their planned procedure with no intervention during intubation. The clip group will undergo their planned procedure as normal but with the endotracheal tube support device placed on the endotracheal tube by the assigned anesthesia attending physician. The clip is placed once the tube is secured and the ventilator circuit is connected. While extubating the patient, the endotracheal tube will be removed with the clip attached and a picture of the tube will be taken to record the clip location.
Before the planned procedure, the investigators will survey the participants to get a baseline for any pre-existing laryngeal symptoms. The same survey will be administered after the procedure when the participants are awake and alert just prior to discharge, 24 hours, 48 hours, and 1 week after the procedure. The survey will ask the participant to indicate "yes" or "no" for whether they are experiencing a sore throat, throat pain, oral pain, difficulty speaking, difficulty swallowing, changes in their voice, pain while speaking, and pain while swallowing. If they have indicated "yes" for any of the symptoms, the participants will also be asked to mark the severity on a visual analog scale from 1 to 10.
Other data points will also be collected in this study that are related to the intubation and participant's airway. The investigators will record the total time of the procedure and the length of time the clip is placed on the endotracheal tube. For each participant in the clip group, the investigators will also record the time it takes to place the clip on the endotracheal tube. Each participant's airway will be evaluated, and the investigators will record the thyromental distance, Mallampati score, history of difficult intubation, and the size of the endotracheal tube used. Lastly, data from each participant's intubation will be collected including number of attempts before successful intubation, incidence of dental injury, incidence of lip injury, laryngeal view on Cormack-Lehane scale, and any noted trauma upon extubation. Lastly, the investigators will have the anesthesiologists recruited for the study fill out a modified National Aeronautics and Space Administration (NASA) Task Load Index (TLX) form to evaluate the end-user experience for the device.
- Conditions
- Sore-throat, Dysphonia, Dysphagia, Intubation Complication, Anesthesia Intubation Complication, Anesthesia Morbidity
- Being tested
- EndoClip
- Keywords
- Endotracheal tube, Anesthesia, Sore throat, Throat pain, Dysphonia, Dysphagia, Throat injury, General anesthesia, Intubation, Endotracheal intubation, Breathing tube, Odynophonia, Odynophagia
- Medical subject headings
- Pharyngitis, Dysphonia, Deglutition Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoClipDevice
Also called Endotracheal tube clip
Clip attached to mid portion of the endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| EndoClip | Experimental | Clip applied to endotracheal tube. Receives: Device: EndoClip |
| No Clip | No intervention | No clip applied to endotracheal tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat)
Subjects will indicate whether they are experiencing a sore throat or throat discomfort on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no sore throat) to 10 (worst possible sore throat). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Measured: Baseline to 1 week after intervention
Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change)
Subjects will indicate whether they are experiencing a change in voice (i.e. deep and/or hoarse voice, worse than their usual voice quality) on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no voice change) to 10 (most severe voice change). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Measured: Baseline to 1 week after intervention
Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow)
Subjects will indicate whether they are experiencing difficulty swallowing on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty swallowing) to 10 (complete inability to swallow). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Measured: Baseline to 1 week after intervention
Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain)
Subjects will indicate whether they are experiencing mouth pain on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no mouth pain) to 10 (worst possible mouth pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Measured: Baseline to 1 week after intervention
Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk)
Subjects will indicate whether they are experiencing difficulty talking on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty talking) to 10 (complete inability to talk). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Measured: Baseline to 1 week after intervention
Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain)
Subjects will indicate whether they are experiencing pain in the anterior or low region of the neck and/or chest on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Measured: Baseline to 1 week after intervention
Patients With Post Operative Mouth Pain
Patients with post operative mouth pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Measured: 7 days
Patients With Post Operative Sore Throat
Patients with post operative sore throat during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Measured: 7 days
Patients With Post Operative Neck/Chest Pain
Patients with post operative neck/chest pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Measured: 7 days
Patients With Post Operative Voice Change
Patients with post operative voice change over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Measured: 7 days
Patients With Post Operative Difficulty Talking
Patients with post operative difficulty talking over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Measured: 7 days
Patients With Post Operative Difficulty Swallowing
Patients with post operative difficulty swallowing over there first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start8 Nov 2022
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sore-throatStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm parallel trial where one group will receive the endotracheal tube clip during general endotracheal anesthesia and the other group will not.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Vahabzadeh-Hagh, University of California, San Diego
- Investigators
- Andrew Vahabzadeh-Hagh, MD, Principal investigator, UC San Diego Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383417
- Sponsor's protocol ID
- 800842
- Acronym
- No-PILS
- Status last verified
- Sep 2025
- First submitted
- 10 May 2022
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Tube Clip for Prevention of Post Intubation Laryngeal Symptoms
- ClinicalTrials.gov ID
- NCT05383417
- Acronym / sponsor ID
- No-PILS / 800842
- Conditions
- Sore-throat, Dysphonia, Dysphagia, Intubation Complication, Anesthesia Intubation Complication, Anesthesia Morbidity
- Keywords
- Endotracheal tube, Anesthesia, Sore throat, Throat pain, Dysphonia, Dysphagia, Throat injury, General anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing.
Detailed description
Single center randomized controlled trial with 100 subjects who will be intubated for already planned surgeries. The participants will be randomized into the control group or the clip group. The clip group will have a small clip (the endotracheal tube support device) placed on the endotracheal tube to reduce the pressure on the vocal cords and larynx. This endotracheal tube support device is made from a FDA approved biocompatible material.
The control group subjects will undergo their planned procedure with no intervention during intubation. The clip group will undergo their planned procedure as normal but with the endotracheal tube support device placed on the endotracheal tube by the assigned anesthesia attending physician. The clip is placed once the tube is secured and the ventilator circuit is connected. While extubating the patient, the endotracheal tube will be removed with the clip attached and a picture of the tube will be taken to record the clip location.
Before the planned procedure, the investigators will survey the participants to get a baseline for any pre-existing laryngeal symptoms. The same survey will be administered after the procedure when the participants are awake and alert just prior to discharge, 24 hours, 48 hours, and 1 week after the procedure. The survey will ask the participant to indicate "yes" or "no" for whether they are experiencing a sore throat, throat pain, oral pain, difficulty speaking, difficulty swallowing, changes in their voice, pain while speaking, and pain while swallowing. If they have indicated "yes" for any of the symptoms, the participants will also be asked to mark the severity on a visual analog scale from 1 to 10.
Other data points will also be collected in this study that are related to the intubation and participant's airway. The investigators will record the total time of the procedure and the length of time the clip is placed on the endotracheal tube. For each participant in the clip group, the investigators will also record the time it takes to place the clip on the endotracheal tube. Each participant's airway will be evaluated, and the investigators will record the thyromental distance, Mallampati score, history of difficult intubation, and the size of the endotracheal tube used. Lastly, data from each participant's intubation will be collected including number of attempts before successful intubation, incidence of dental injury, incidence of lip injury, laryngeal view on Cormack-Lehane scale, and any noted trauma upon extubation. Lastly, the investigators will have the anesthesiologists recruited for the study fill out a modified National Aeronautics and Space Administration (NASA) Task Load Index (TLX) form to evaluate the end-user experience for the device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arm parallel trial where one group will receive the endotracheal tube clip during general endotracheal anesthesia and the other group will not.
| Arm | Type | Receives |
|---|---|---|
| EndoClip | Experimental | Device: EndoClipClip applied to endotracheal tube. |
| No Clip | No intervention | –No clip applied to endotracheal tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing general endotracheal anesthesia with an endotracheal tube
- Patient is not undergoing a procedure in the head and neck region
Key exclusion criteria (2 listed)
- Patient with pre-existing severe sore throat, voice change, or trouble swallowing
- Patient undergoing surgery in the head and neck region
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 |
|---|---|---|
| EndoClipAlso: Endotracheal tube clipClip attached to mid portion of the endotracheal tube. | Device | EndoClip |
Primary outcome
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat)
Time frame: Baseline to 1 week after intervention
Subjects will indicate whether they are experiencing a sore throat or throat discomfort on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no sore throat) to 10 (worst possible sore throat). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change)
Time frame: Baseline to 1 week after intervention
Subjects will indicate whether they are experiencing a change in voice (i.e. deep and/or hoarse voice, worse than their usual voice quality) on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no voice change) to 10 (most severe voice change). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow)
Time frame: Baseline to 1 week after intervention
Subjects will indicate whether they are experiencing difficulty swallowing on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty swallowing) to 10 (complete inability to swallow). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain)
Time frame: Baseline to 1 week after intervention
Subjects will indicate whether they are experiencing mouth pain on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no mouth pain) to 10 (worst possible mouth pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk)
Time frame: Baseline to 1 week after intervention
Subjects will indicate whether they are experiencing difficulty talking on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty talking) to 10 (complete inability to talk). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain)
Time frame: Baseline to 1 week after intervention
Subjects will indicate whether they are experiencing pain in the anterior or low region of the neck and/or chest on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Patients With Post Operative Mouth Pain
Time frame: 7 days
Patients with post operative mouth pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Patients With Post Operative Sore Throat
Time frame: 7 days
Patients with post operative sore throat during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Patients With Post Operative Neck/Chest Pain
Time frame: 7 days
Patients with post operative neck/chest pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Patients With Post Operative Voice Change
Time frame: 7 days
Patients with post operative voice change over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Patients With Post Operative Difficulty Talking
Time frame: 7 days
Patients with post operative difficulty talking over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Patients With Post Operative Difficulty Swallowing
Time frame: 7 days
Patients with post operative difficulty swallowing over there first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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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.
Andrew Vahabzadeh-Hagh, MD principal investigator
UC San Diego Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoClip in people with Sore-throat and Dysphonia, run by University of California, San Diego at 1 site in United States.
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 2 inclusion and 2 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 Sep 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) (time frame: Baseline to 1 week after intervention). The study lists 12 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 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.