An interventional study of Direct laryngoscopy force modulation and Direct laryngoscopy without force modulation in Laryngeal Disease, Post-operative Pain and Tongue Injury, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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.
136 studies on the registry are indexed under Laryngeal Diseases; 23 are open to participants now.
This study's planned enrollment of 100 is above the median of 41 across 111 interventional studies indexed under Laryngeal Diseases.
Browse Laryngeal Diseases studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected.
Procedure: Direct laryngoscopy without force modulation
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.
Procedure: Direct laryngoscopy force modulation
Modification of applied force during direct laryngoscopy using real-time force sensor measurements.
Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force
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
Time frame: 1 day, 14 days, and 1 month post-operatively
Tongue mobility
Assessment of changes in tongue mobility post-operatively. My physician report Tongue deviation is: 0 - absent 1 - present
Time frame: 1 month post-operatively
Tongue sensation
Assessment of changes in tongue sensation post-operatively, according to patient report: My tongue numbness is: 0 - absent 1. \- minimal 2. \- mild 3. \- moderatre 4. \- severe
Time frame: 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
Time frame: 1 day, 14 days, 1 month post-operatively
Plan to share: No
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University of California, San Francisco