Force Sensor Study

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07434583
Status
Recruiting
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Conditions

  • Laryngeal Disease
  • Post-operative Pain
  • Tongue Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Direct laryngoscopy force modulation — PROCEDURE
    Modification of applied force during direct laryngoscopy using real-time force sensor measurements.
  • Direct laryngoscopy without force modulation — PROCEDURE
    Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force

Study Details

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.

Key Dates

Start date
Jan 2, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Surgeon blinded
    Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected.
  • Experimental: Surgeon unblinded
    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.

Primary Outcome Measure

Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 1 day, 14 days, and 1 month post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94115
Tyler Crosby
[email protected]
Tyler Crosby, MD (PRINCIPAL_INVESTIGATOR)

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University of California San Francisco· San Francisco, CA

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