Force Sensor Study

Biomechanical Analysis of Force Loadings During Suspension Microlaryngoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain; Laryngeal Disease; Tongue Injury
• Intervention / Treatment: Procedure: Direct laryngoscopy without force modulation; Procedure: Direct laryngoscopy force modulation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riley Jackson; Phone Number: 6282526882; Email: riley.jackson@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Recruiting
      • University of California San Francisco
      • Contact: Tyler Crosby; Email: tyler.crosby@ucsf.edu
      • Principal Investigator: Tyler Crosby, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgeon blinded; 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 as is done in standard of care without active modulation of applied force
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.	Procedure: Direct laryngoscopy force modulation; Modification of applied force during direct laryngoscopy using real-time force sensor measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue mobility	Assessment of changes in tongue mobility post-operatively. My physician report Tongue deviation is: 0 - absent 1 - present	1 month post-operatively
Tongue sensation	Assessment of changes in tongue sensation post-operatively, according to patient report: My tongue numbness is: 0 - absent; - minimal; - mild; - moderatre; - severe	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	1 day, 14 days, 1 month post-operatively

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Tyler Crosby, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Laryngeal Diseases
• Other Study ID Numbers: 24-42623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No