Force Sensor Study

NCT07434583 | Recruiting

• 1 other identifier: 24-42623
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 day, 14 days, and 1 month post-operatively

Secondary Outcomes (3)

• Tongue mobility

  1 month post-operatively

• Tongue sensation

  1 day, 14 days, and 1 month post-operatively

• Change in taste

  1 day, 14 days, 1 month post-operatively

Study Arms (2)

Surgeon blinded

ACTIVE COMPARATOR

Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected.

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.

Procedure: Direct laryngoscopy force modulation

Interventions

Direct laryngoscopy force modulation PROCEDURE

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

Surgeon unblinded

Direct laryngoscopy without force modulation PROCEDURE

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

Surgeon blinded

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Laryngeal Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Tyler Crosby, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riley Jackson

CONTACT

6282526882; riley.jackson@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 25, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)