[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579120":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":51,"interventions":63,"overallOfficials":71,"centralContacts":76,"locations":81,"responsibleParty":95,"collaborators":44,"id":98,"slug":44,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":44,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":44,"enrollmentInfo":107,"targetDuration":44,"studyType":110,"phases":111,"briefSummary":114,"conditions":115,"keywords":44,"overallStatus":83,"whyStopped":44,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"West Virginia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":44,"otherOutcomes":44},[9,13,15,17,19,22,24,26,28,32,36,40],{"measure":10,"description":11,"timeFrame":12},"Post-Injection Pain (First Treatment)","Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced.","15 minutes post injection (treatment)",{"measure":14,"description":11,"timeFrame":12},"Post-Injection Pain (Second Treatment)",{"measure":16,"description":11,"timeFrame":12},"Post-Injection Pain (Third Treatment)",{"measure":18,"description":11,"timeFrame":12},"Post-Injection Pain (Forth Treatment)",{"measure":20,"description":21,"timeFrame":12},"Post-injection erythema (First Treatment)","Post-injection erythema is assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema. The higher score indicates a worse outcome.",{"measure":23,"description":21,"timeFrame":12},"Post-injection erythema (Second Treatment)",{"measure":25,"description":21,"timeFrame":12},"Post-injection erythema (Third Treatment)",{"measure":27,"description":21,"timeFrame":12},"Post-injection erythema (Forth Treatment)",{"measure":29,"description":30,"timeFrame":31},"Change in Lipoma Size (Second Treatment)","Change in Lipoma Size from the First Treatment (Baseline) to the Second Treatment. There is a 4 week interval between each treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \\[(final area - initial area) ÷ initial area\\] × 100.","Baseline to Second Treatment (4-week interval between treatments)",{"measure":33,"description":34,"timeFrame":35},"Change in Lipoma Size (Third Treatment)","Change in Lipoma Size from the First Treatment (Baseline) to the Third Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \\[(final area - initial area) ÷ initial area\\] × 100.","Baseline to Third Treatment (4-week interval between treatments)",{"measure":37,"description":38,"timeFrame":39},"Change in Lipoma Size (Forth Treatment)","Change in Lipoma Size from the First Treatment (Baseline) to the Forth Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \\[(final area - initial area) ÷ initial area\\] × 100.","Baseline to Forth Treatment (4-week interval between treatments)",{"measure":41,"description":42,"timeFrame":43},"Change in Lipoma Size (12 weeks following the Fourth Treatment)","Change in Lipoma Size from the First Treatment (Baseline) to 12 weeks following the Fourth Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \\[(final area - initial area) ÷ initial area\\] × 100.","From Baseline to 12 weeks following the Fourth Treatment",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Cooled Sodium Chloride Injection","EXPERIMENTAL","Injection of a solution containing sterile, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000). Each patient will receive a volume of solution equal to three times the estimated volume of the lipoma; the first cc of the injection will be lidocaine with epinephrine, and the remainder will be sterile normal saline. The solution will be cooled using an ice\u002Fsaline bath at -1°C. Following the injection, the lipoma will be gently massaged for one minute to distribute the saline evenly.",[57],"Drug: Cooled Sodium Chloride Injection",{"label":59,"type":54,"description":60,"interventionNames":61},"Warmed Sodium Chloride Injection","Injection of a solution containing sterile, warm 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000). Each patient will receive a volume of solution equal to three times the estimated volume of the lipoma; the first cc of the injection will be lidocaine with epinephrine, and the remainder will be sterile normal saline. The saline vials and syringes will both be warmed using a Thermo Fisher Scientific dry bath calibrated to 55°C; a precise temperature stability will be achieved by using a mercury thermometer. Following the injection, the lipoma will be gently massaged for one minute to distribute the saline evenly.",[62],"Drug: Warmed Sodium Chloride Injection",[64,68],{"type":65,"name":53,"description":66,"armGroupLabels":67,"otherNames":44},"DRUG","A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).",[53],{"type":65,"name":59,"description":69,"armGroupLabels":70,"otherNames":44},"A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, warmed 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).",[59],[72],{"name":73,"affiliation":74,"role":75},"Jessica Patterson, MD","West Virginia University-Dermatology","PRINCIPAL_INVESTIGATOR",[77],{"name":73,"role":78,"phone":79,"phoneExt":44,"email":80},"CONTACT","304-598-4865","jpatter5@hsc.wvu.edu",[82],{"facility":5,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":44},"RECRUITING","Morgantown","West Virginia","26505","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-79.9559,39.62953,{"lat":93,"lon":92},{"type":75,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Jessica Patterson","Assistant Professor","100579120",false,"NCT06820164","Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride","Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride: an Exploratory Study","Inclusion Criteria:\n\n* At least one clinically diagnosed subcutaneous lipoma\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Participant has a lipoma on the face\n* Lipomas located subfascial or within deep tissue (e.g., intramuscular lipomas)\n* Lipomas larger than 10 cm in diameter (fat deposits exceeding 500 mL in volume)\n* Rapidly growing lipomas\n* Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance)\n* Pregnant women",true,"ALL","18 Years",{"count":108,"type":109},20,"ESTIMATED","INTERVENTIONAL",[112,113],"PHASE1","PHASE2","Lipomas are benign tumors composed of mature adipose tissue. While harmless, these are the most common type of soft tissue growths with some patients developing numerous lipomas. Patients often seek removal for cosmesis, or symptoms caused by location and\u002For compression of surrounding structures. This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas. The study will assess whether this technique could serve as a viable alternative to existing treatment options, especially compared to topically applied fat-freezing devices. The Investigators propose that this method may offer a more comfortable nonsurgical option for targeted fat reduction, as the cold temperatures are applied directly to the lipomas.\n\nAmendment to Protocol Feb 2026- Including and additional ARM of the study to evaluate the effectiveness of subcutaneous injections of warmed normal saline as a treatment option for lipomas.",[116],"Lipoma","2026-04-23",{"date":119,"type":120},"2026-04-29","ACTUAL",{"date":122,"type":120},"2025-05-08",{"date":124,"type":109},"2027-01",{"name":5,"class":6},1]