Recruiting

Oropharyngeal Forces

Sponsor:

UCLA

Code:

NCT07434583

Conditions

Laryngeal Disease

Post-operative Pain

Tongue Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Direct laryngoscopy force modulation

Direct laryngoscopy without force modulation

Study Details

Brief 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 (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

Study ID

NCT07434583

Start date

Jan 2, 2026

Status verified date

Feb, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Direct laryngoscopy force modulation

Modification of applied force during direct laryngoscopy using real-time force sensor measurements.

Direct laryngoscopy without force modulation

Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Riley Jackson

6282526882riley.jackson@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Tyler Crosby

tyler.crosby@ucsf.edu

Principal Investigator:

Tyler Crosby, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-02-25.