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NCT Number: NCT07434583

Force Sensor Study

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.

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Key information

Conditions

Laryngeal Disease Laryngeal Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Respiratory Tract Diseases Signs and Symptoms Tongue Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94115, United States

Location status: Recruiting

Location contact

Tyler Crosby

CONTACT

[email protected]

Tyler Crosby, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years old with
  • undergoing laryngeal surgery with direct laryngoscopy

Exclusion criteria

  • Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury
  • Patient inability to follow up after initial procedure

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Tongue mobility

    Time frame: 1 month post-operatively

    Assessment of changes in tongue mobility post-operatively. My physician report

    Tongue deviation is:

    0 - absent

    1 - present

  2. Tongue sensation

    Time frame: 1 day, 14 days, and 1 month post-operatively

    Assessment of changes in tongue sensation post-operatively, according to patient report:

    My tongue numbness is:

    0 - absent

    • - minimal
    • - mild
    • - moderatre
    • - severe

  3. Change in taste

    Time frame: 1 day, 14 days, 1 month post-operatively

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Riley Jackson

CONTACT

[email protected]

6282526882

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Biomechanical Analysis of Force Loadings During Suspension Microlaryngoscopy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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