[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07434583":3,"trial-entities:NCT07434583":99,"trial-summary:NCT07434583":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":69,"locations":72,"central_contacts":90,"overall_officials":95,"references":97,"see_also_links":98},"NCT07434583","24-42623","Force Sensor Study","Biomechanical Analysis of Force Loadings During Suspension Microlaryngoscopy","RECRUITING","2027-01-31","2026-02","2026-02-25","2026-01-02","University of California, San Francisco","OTHER",false,"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.\n\nFor the first 50 patients, force measurements will be taken and correlated to outcome measures . Surgeons will be blinded to the force measurements intra-operatively.\n\nFor 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.",null,[19,20,21],"Laryngeal Disease","Post-operative Pain","Tongue Injury",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},100,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"PROCEDURE","Direct laryngoscopy force modulation","Modification of applied force during direct laryngoscopy using real-time force sensor measurements.",[36],"Surgeon unblinded",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Direct laryngoscopy without force modulation","Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force",[41],"Surgeon blinded",[43],{"measure":44,"description":45,"timeFrame":46},"Short Form McGill Pain Questionnaire (SF-MPQ)","The SF-MPQ includes the following components:\n\n15 descriptors:\n\n* 11 sensory, each rated 0=none, 1=mild, 2=moderate, 3=severe\n* 4 affective , each rated 0=none, 1=mild, 2=moderate, 3=severe.\n\nA 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",[48,52,55],{"measure":49,"description":50,"timeFrame":51},"Tongue mobility","Assessment of changes in tongue mobility post-operatively. My physician report\n\nTongue deviation is:\n\n0 - absent\n\n1 - present","1 month post-operatively",{"measure":53,"description":54,"timeFrame":46},"Tongue sensation","Assessment of changes in tongue sensation post-operatively, according to patient report:\n\nMy tongue numbness is:\n\n0 - absent\n\n1. \\- minimal\n2. \\- mild\n3. \\- moderatre\n4. \\- severe",{"measure":56,"description":57,"timeFrame":58},"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","ALL","18 Years",{"inclusion":62,"exclusion":65,"raw_text":68},[63,64],"\\>18 years old with","undergoing laryngeal surgery with direct laryngoscopy",[66,67],"Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury","Patient inability to follow up after initial procedure","Inclusion Criteria:\n\n* \\>18 years old with\n* undergoing laryngeal surgery with direct laryngoscopy\n\nExclusion Criteria:\n\n* Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury\n* Patient inability to follow up after initial procedure",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":87},"University of California San Francisco","San Francisco","California","94115","United States",[80,84],{"name":81,"role":82,"email":83},"Tyler Crosby","CONTACT","tyler.crosby@ucsf.edu",{"name":85,"role":86},"Tyler Crosby, MD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},37.77493,-122.41942,[91],{"name":92,"role":82,"phone":93,"email":94},"Riley Jackson","6282526882","riley.jackson@ucsf.edu",[96],{"name":85,"affiliation":13,"role":86},[],[],{"nct_id":4,"conditions":100,"biomarkers":104},[101,102,103],"Injury of tongue","Laryngeal Disorder","Post-Operative Pain",[],{"nct_id":4,"found":106,"summary":107,"prompt_version":117},true,{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an interventional study planning to enroll 100 participants. It compares direct laryngoscopy with force modulation to direct laryngoscopy without force modulation, with surgeons blinded to force measurements for the first 50 patients.","completed","Force Sensor Study for Laryngeal Surgery","This study is looking at how much force is applied to your tongue and throat during direct laryngoscopy (a procedure where a doctor looks at your voice box) for laryngeal surgery. Researchers want to see if changing this force, using real-time measurements from a force sensor, can affect outcomes like pain, numbness, or taste after surgery. You would either have direct laryngoscopy with force modulation (where the force is adjusted) or without force modulation (standard care). The study will measure your pain using the Short Form McGill Pain Questionnaire at 1 day, 14 days, and 1 month after your surgery. This study is for adults aged 18 and older who are having laryngeal surgery with direct laryngoscopy. The study is currently unclear on its recruitment status and plans to enroll 100 participants.","You will be followed for 1 month after your procedure to assess pain levels.",132,"You would undergo direct laryngoscopy as part of your laryngeal surgery. Your pain levels will be measured using a questionnaire at 1 day, 14 days, and 1 month after your surgery.","Not stated in the trial record.",[],"v2"]