Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 1:19 AM
Study NCT ID:
NCT01097603
Status:
COMPLETED
Last Update Posted:
2010-04-01
First Post:
2010-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2010-03-31', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-03-31', 'lastUpdatePostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-Invasive Blood Pressure'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and pediatric population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Total 92 numbers of subjects or patients were studied during this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Subjects: Healthy volunteers\n\nInclusion Criteria:\n\n* Healthy subjects\n* Age between 1 - 60 yrs\n* Both genders\n* Consenting for the study\n\nExclusion Criteria:\n\n* Subjects suffering from cardiorespiratory, neurological or endocrinal disorders\n* Subjects with alcohol abuse/dependance\n* Female subjects who are pregnant or lactating\n* Subjects with pace maker implantations\n\nSubjects: Diseased subjects\n\nInclusion Criteria:\n\n* Patients of hypertensive, ICU and in patients of different diseases\n* Age between 1 - 80 yrs\n* Both genders\n* Consenting for the study\n\nExclusion Criteria:\n\n* Healthy volunteers'}, 'identificationModule': {'nctId': 'NCT01097603', 'briefTitle': 'Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Larsen & Toubro Limited'}, 'officialTitle': 'L&T Noninvasive Blood Pressure Module Performance Validation', 'orgStudyIdInfo': {'id': 'LTMED01-0310'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larsen & Toubro Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'L&T MEDICAL EQUIPMENTS & SYSTEMS, MYSORE,INDIA', 'oldOrganization': 'LARSEN & TOUBRO LIMITED'}}}}