Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:24 PM
Study NCT ID:
NCT07396961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consistency of ASIS Line vs. Tuffier's Line for Lumbar Level Identification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010173', 'term': 'Palpation'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consistency of Vertebral Level Identification (Standard Deviation)', 'timeFrame': 'Day 1 (Immediately during the ultrasound examination)', 'description': "The specific vertebral level where the ASIS line and Tuffier's line intersect the spine will be identified using ultrasound. The lumbar spine (from L2 upper to S1 upper) is divided into segments (e.g., L2=2, L3=3, L4=4, L5=5, S1=6). The consistency of each method is evaluated by calculating and comparing the standard deviation (SD) of the identified vertebral levels."}], 'secondaryOutcomes': [{'measure': 'Difference in Mean Intersection Level', 'timeFrame': 'Day 1', 'description': "Comparison of the mean vertebral levels identified by the ASIS line versus Tuffier's line to determine if there is a significant difference in the average level indicated."}, {'measure': 'Rate of Identification within L4-L5 Interspace', 'timeFrame': 'Day 1', 'description': 'The percentage of cases where the identified line falls within the target L4-L5 interspace (or within ±1 interspace range).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vertebral level', 'Ultrasound', "Tuffier's line", 'ASIS', 'Lateral decubitus position'], 'conditions': ['Spinal Anesthesia Evaluation', 'Lumbar Vertebrae']}, 'descriptionModule': {'briefSummary': 'Tuffier\'s line is commonly used as a landmark for estimating lumbar vertebral levels during spinal anesthesia. However, its accuracy can vary depending on factors such as age, sex, BMI, and posture. This study evaluates the consistency of an alternative landmark, the "ASIS line" (a line connecting both Anterior Superior Iliac Spines), for identifying lumbar levels in the lateral decubitus position. Researchers will mark both the ASIS line and Tuffier\'s line on participants and use ultrasound to verify the exact vertebral level where each line crosses the spine. The goal is to determine if the ASIS line provides a more consistent and reliable estimation of lumbar levels compared to Tuffier\'s line.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients visiting the study centers (Kangbuk Samsung Hospital or St. Vincent's Hospital) who are scheduled for spinal anesthesia or lumbar ultrasound.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 85 years\n* Patients scheduled for spinal anesthesia or lumbar ultrasound\n* Participants who voluntarily agreed to participate and provided written informed consent\n\nExclusion Criteria:\n\n* History of spinal surgery or spinal deformity\n* Infection or wounds at the puncture site\n* Inability to maintain the lateral decubitus position\n* Congenital lumbosacral transitional vertebrae (e.g., sacralized L5 or lumbarized S1)\n* Any other condition deemed unsuitable for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT07396961', 'briefTitle': "Consistency of ASIS Line vs. Tuffier's Line for Lumbar Level Identification", 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': "Evaluation of the Consistency of the ASIS Line for Lumbar Level Identification in the Lateral Decubitus Position: Comparison With the Tuffier's Line", 'orgStudyIdInfo': {'id': '2026-01-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Cohort', 'description': 'Adult patients (aged 18-85) scheduled for spinal anesthesia or lumbar ultrasound', 'interventionNames': ['Diagnostic Test: Lumbar Ultrasound & Palpation']}], 'interventions': [{'name': 'Lumbar Ultrasound & Palpation', 'type': 'DIAGNOSTIC_TEST', 'description': "Identification of vertebral levels using Tuffier's line (palpation) and ASIS line, followed by ultrasound verification.", 'armGroupLabels': ['Study Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27516', 'city': 'Suwon', 'state': 'North Carolina', 'country': 'South Korea', 'contacts': [{'name': 'Yoo Jung Park', 'role': 'CONTACT', 'email': 'genial7@naver.com', 'phone': '+ 82-31-249-8446'}, {'name': 'SUNG HYUN LEE', 'role': 'CONTACT', 'email': '4321hoho@naver.com', 'phone': '+82-1-2001-2323'}], 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Sung Hyun Ldd, MD, PhD', 'role': 'CONTACT', 'email': 'hoho4321.lee@samsung.com'}], 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sung Hyun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'hoho4321.lee@samsung.com', 'phone': '+82-2-2001-1666'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sung Hyun Lee', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}