Laryngeal DiseaseNCT07434583
Force Sensor Study
A study testing Direct laryngoscopy force modulation and Direct laryngoscopy without force modulation in people with Laryngeal Disease and Post-operative Pain, run by University of California, San Francisco at 1 site in United States.
Trial summary
This research is to understand more about the forces that are involved on the tongue and other oropharyngeal structures during laryngeal surgery. This information will be used to determine if these forces can affect outcomes (pain, numbness, taste, etc) and whether factors such as procedure type, surgeon experience… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Disease, Post-operative Pain, Tongue Injury
- What is being tested?
- Direct laryngoscopy force modulation and Direct laryngoscopy without force modulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old with
- undergoing laryngeal surgery with direct laryngoscopy
Who cannot join
- Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury
- Patient inability to follow up after initial procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Tyler Crosby, tyler.crosby@ucsf.edu
Tyler Crosby, MD
About this study
Official title: Biomechanical Analysis of Force Loadings During Suspension Microlaryngoscopy
This research is to understand more about the forces that are involved on the tongue and other oropharyngeal structures during laryngeal surgery. This information will be used to determine if these forces can affect outcomes (pain, numbness, taste, etc) and whether factors such as procedure type, surgeon experience (i.e. resident, fellow, attending), and choice of surgical equipment affect these forces. This information may be used to reduce these forces and prevent these issues from happening during certain laryngeal surgeries.
For the first 50 patients, force measurements will be taken and correlated to outcome measures . Surgeons will be blinded to the force measurements intra-operatively.
For the next 50 patients, surgeons will be given force measurements in real-time intra-operatively allowing adjustments to be made. The impact of this adjustment on outcomes will be determined.
- Conditions
- Laryngeal Disease, Post-operative Pain, Tongue Injury
- Being tested
- Direct laryngoscopy force modulation, Direct laryngoscopy without force modulation
- Medical subject headings
- Laryngeal Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscopy force modulationProcedure or surgery
Modification of applied force during direct laryngoscopy using real-time force sensor measurements.
Direct laryngoscopy without force modulationProcedure or surgery
Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force
| Study group | Role | What they receive |
|---|---|---|
| Surgeon blinded | Active comparator | Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected. Receives: Procedure: Direct laryngoscopy without force modulation |
| Surgeon unblinded | Experimental | Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. The surgeon will be aware of force measurements in real-time, allowing for adjustments to reduce applied force during direct laryngoscopy. Post-operative outcome measures will be collected. Receives: Procedure: Direct laryngoscopy force modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ includes the following components:
15 descriptors:
- 11 sensory, each rated 0=none, 1=mild, 2=moderate, 3=severe
- 4 affective , each rated 0=none, 1=mild, 2=moderate, 3=severe.
A Present Pain Intensity (PPI) scale (0=No Pain, 1=Mild, 2=Discomforting, 3=Distressing, 4=Horrible, 5=Excruciating) Visual Analogue Scale of average pain (VAS, 0-10 cm) - higher score is worse pain
Measured: 1 day, 14 days, and 1 month post-operatively
Secondary outcomes (3)
Tongue mobility
Assessment of changes in tongue mobility post-operatively. My physician report
Tongue deviation is:
0 - absent
1 - present
Measured: 1 month post-operatively
Tongue sensation
Assessment of changes in tongue sensation post-operatively, according to patient report:
My tongue numbness is:
0 - absent
- - minimal
- - mild
- - moderatre
- - severe
Measured: 1 day, 14 days, and 1 month post-operatively
Change in taste
Assessment of changes in taste post-operatively, according to patient report: My tongue numbness is: 0 - absent 1 - minimal 2 - mild 3 - moderatre 4 - severe
Measured: 1 day, 14 days, 1 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start2 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler Crosby, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434583
- Sponsor's protocol ID
- 24-42623
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Analysis of Force Loadings During Suspension Microlaryngoscopy
- ClinicalTrials.gov ID
- NCT07434583
- Acronym / sponsor ID
- 24-42623
- Conditions
- Laryngeal Disease, Post-operative Pain, Tongue Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 25 Feb 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.
This research is to understand more about the forces that are involved on the tongue and other oropharyngeal structures during laryngeal surgery. This information will be used to determine if these forces can affect outcomes (pain, numbness, taste, etc) and whether factors such as procedure type, surgeon experience (i.e. resident, fellow, attending), and choice of surgical equipment affect these forces. This information may be used to reduce these forces and prevent these issues from happening during certain laryngeal surgeries.
For the first 50 patients, force measurements will be taken and correlated to outcome measures . Surgeons will be blinded to the force measurements intra-operatively.
For the next 50 patients, surgeons will be given force measurements in real-time intra-operatively allowing adjustments to be made. The impact of this adjustment on outcomes will be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon blinded | Active comparator | Procedure: Direct laryngoscopy without force modulationPatients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected. |
| Surgeon unblinded | Experimental | Procedure: Direct laryngoscopy force modulationPatients will undergo direct laryngoscopy with force measurements taken intra-operatively. The surgeon will be aware of force measurements in real-time, allowing for adjustments to reduce applied force during direct laryngoscopy. Post-operative outcome measures will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years old with
- undergoing laryngeal surgery with direct laryngoscopy
Key exclusion criteria (2 listed)
- Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury
- Patient inability to follow up after initial procedure
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 |
|---|---|---|
| Direct laryngoscopy force modulationModification of applied force during direct laryngoscopy using real-time force sensor measurements. | Procedure or surgery | Surgeon unblinded |
| Direct laryngoscopy without force modulationPatients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force | Procedure or surgery | Surgeon blinded |
Primary outcome
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 1 day, 14 days, and 1 month post-operatively
The SF-MPQ includes the following components: 15 descriptors: * 11 sensory, each rated 0=none, 1=mild, 2=moderate, 3=severe * 4 affective , each rated 0=none, 1=mild, 2=moderate, 3=severe. A Present Pain Intensity (PPI) scale (0=No Pain, 1=Mild, 2=Discomforting, 3=Distressing, 4=Horrible, 5=Excruciating) Visual Analogue Scale of average pain (VAS, 0-10 cm) - higher score is worse pain
3 secondary outcomes
Tongue mobility
Time frame: 1 month post-operatively
Tongue sensation
Time frame: 1 day, 14 days, and 1 month post-operatively
Change in taste
Time frame: 1 day, 14 days, 1 month post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Tyler Crosby, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct laryngoscopy force modulation and Direct laryngoscopy without force modulation in people with Laryngeal Disease and Post-operative Pain, run by University of California, San Francisco 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: looking for participants now, as of the sponsor's last update on 25 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riley Jackson (6282526882, riley.jackson@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form McGill Pain Questionnaire (SF-MPQ) (time frame: 1 day, 14 days, and 1 month post-operatively). 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 25 Feb 2026.