Force Modulation for Laryngeal Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Tyler Crosby, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Surgeon Blinded
Force measurements are taken intra-operatively with surgeons blinded to the measurements. Post-operative outcome measures are collected.
Treatment - Surgeon Unblinded
Force measurements are taken intra-operatively with surgeons aware of the measurements, allowing for adjustments. Post-operative outcome measures are collected.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of pain, tongue mobility, sensation, and taste.
What Are the Treatments Tested in This Trial?
Interventions
- Direct Laryngoscopy Force Modulation
- Direct Laryngoscopy without Force Modulation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
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