Nctid:
NCT06612450
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015508", "term"=>"Nasal Obstruction"}], "ancestors"=>[{"id"=>"D000009668", "term"=>"Nose Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000000402", "term"=>"Airway Obstruction"}, {"id"=>"D000012131", "term"=>"Respiratory Insufficiency"}, {"id"=>"D000012120", "term"=>"Respiration Disorders"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}], "browseLeaves"=>[{"id"=>"M18157", "name"=>"Nasal Obstruction", "asFound"=>"Nasal Obstruction", "relevance"=>"HIGH"}, {"id"=>"M10035", "name"=>"Hypertrophy", "relevance"=>"LOW"}, {"id"=>"M12604", "name"=>"Nose Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M3750", "name"=>"Airway Obstruction", "relevance"=>"LOW"}, {"id"=>"M14968", "name"=>"Respiratory Insufficiency", "relevance"=>"LOW"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"only one surgeon did the surgeries, other two assessors didnt know which intervention was done, the patient didn\\'t know which group did they belong to"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>90}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-06-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-08-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"NOSE score", "timeFrame"=>"1 year", "description"=>"nasal obstruction symptom score for subjective analysis of patient symptom before and after intervention"}, {"measure"=>"Pain VAS score", "timeFrame"=>"1-3 months postoperative", "description"=>"patient score on a scale from 0 to 10 where 0 is no pain and 10 is most severe pain"}, {"measure"=>"Turbinate Size grading", "timeFrame"=>"1 year postoperative", "description"=>"endoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Turbinate Hypertrophy", "Coblation", "Radiofrequency", "Nasal obstruction"], "conditions"=>["Nasal Obstruction", "Turbinate Surgery"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate size over long term clinical follow up visits for 1 year"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nAll patients with the following criteria were eligible for inclusion:\n\n1. Age group: 18-60 years old.\n2. Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.\n3. Evident (HIT) on the CT nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction.\n4. Patients who are unfit for general anesthesia\n\nExclusion Criteria:\n\n* All Patients with:\n\nMarked septal deviation or Concha Bullosa, Nasal polyps, Sinonasal Tumors, Any previous nasal surgeries or radiotherapy, Chronic sinusitis or Cystic Fibrosis, Pregnancy, Patients with severe bleeding tendency, coagulopathy disorder, and Patients who refuse participation in this study were excluded from our study"}, "identificationModule"=>{"nctId"=>"NCT06612450", "briefTitle"=>"Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience", "organization"=>{"class"=>"OTHER", "fullName"=>"Kafrelsheikh University"}, "officialTitle"=>"Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience", "orgStudyIdInfo"=>{"id"=>"MKSU200-289"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Coblation", "description"=>"patients will undergo turbinoplasty using coblation wand", "interventionNames"=>["Device: turbinate surgery"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"RaVoR", "description"=>"patients will undergo turbinate reduction using ravor radiofrequency", "interventionNames"=>["Device: turbinate surgery"]}], "interventions"=>[{"name"=>"turbinate surgery", "type"=>"DEVICE", "description"=>"Turbinoplasty to decrease the turbinate size in cases with turbinate hypertrophy with mainly soft tissue component without sacrificing the mucosal function", "armGroupLabels"=>["Coblation", "RaVoR"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"6850001", "city"=>"Kafr El-sheikh", "country"=>"Egypt", "facility"=>"Kafr El-Sheikh Universitty"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP"], "timeFrame"=>"when results are finalized will be available for 6 months", "ipdSharing"=>"YES", "description"=>"will be shared with results"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Kafrelsheikh University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Dr. Ibrahim Gehad", "investigatorFullName"=>"Ibrahim M. Gehad", "investigatorAffiliation"=>"Kafrelsheikh University"}}}}
