A Photo-based Menstrual Blood Loss Metric
基于照片的月经失血量指标
基本信息
- 批准号:10693342
- 负责人:
- 金额:$ 60.86万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-23 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAgreementAlgorithmic AnalysisAlgorithmsAmericanAreaBlood StainsBlood VolumeBlood specimenCellular PhoneClassificationClinicalClinical ResearchComputer softwareDataDevicesDiagnosisDiseaseDistressEconomic BurdenElectronicsEvaluationFinancial HardshipFundingFutureGoalsGynecologistHematinHemorrhageHigh PrevalenceHomeHospitalsHysterectomyImage AnalysisImpairmentLaboratoriesLeisure ActivitiesLightMeasurementMedicalMenorrhagiaMenstruationMenstruation DisturbancesMethodsMulticenter StudiesOffice VisitsParticipantPatientsPerceptionPhasePhysical activityPhysiciansPilot ProjectsPositioning AttributePremenopauseProceduresQualifyingQuality of CareQuality of lifeRandom AllocationReportingResearchSelf AssessmentSensitivity and SpecificitySeriesSmall Business Innovation Research GrantSpecificitySurfaceSymptomsSystemTamponsTechniquesTestingUnited StatesUnnecessary SurgeryUterine hemorrhageWomanWorkaccurate diagnosisaccurate diagnosticsagedassociated symptomclinical decision-makingclinical diagnosisclinical practicecommercializationcostcost effectivecost estimatediagnostic accuracydiagnostic tooldiarieseffectiveness evaluationeffectiveness validationexperienceexperimental studyimage processinginnovationmobile applicationportabilitypreventreproductivesealsocialtool
项目摘要
Abstract
In the United States, approximately 30% of reproductive aged women suffer from AUB and the associated
symptom of heavy uterine bleeding (menorrhagia), a menstrual disorder that drastically impairs quality of life and
has an annual economic burden of $37 billion. Women afflicted by AUB experience limitations in social, physical,
and leisure activities, and incur a substantial personal financial burden due to work absence and home
management costs (>$2,000 per year). Despite the high prevalence of this medical condition, clinicians rely on
women who are distressed by their menses to give a subjective self-assessment of their menstrual blood loss
(MBL), which has proven to be unreliable for accurate diagnosis and can lead to unnecessary surgery. Given
that these symptoms account for one-third of all office visits to the gynecologist, choosing an appropriate
treatment course is critical for providing high-quality care to Americans. Current methods for quantifying MBL
have key drawbacks that limit their use. Alkaline hematin (AH) testing is the standard required by regulatory
bodies for objective quantification of MBL. Unfortunately, AH testing is impractical for routine clinical practice as
it is expensive (~$1000 per cycle) and has poor acceptability, requiring patients to collect all used sanitary
products and mail them to a lab facility for analysis. While pictorial blood loss assessment charts (PBLACs) offer
a less costly, semi-quantitative method for MBL quantification, they demonstrate a high rate of false positive
results (~59%), which leads to the over-diagnosis of menorrhagia. To address the need for a cost-effective, easy-
to-use, and objective method to quantify MBL in premenopausal women, TheraNova has developed a cell phone-
based diagnostic tool, the electronic MBL Diary (eMBLD). Previously, in a proof of concept clinical study, we
demonstrated a strong correlation between eMBLD and AH testing, the gold-standard method for objective
quantification of MBL. The goals of this Phase II proposal are to determine the effectiveness of our device for
accurately diagnosing menorrhagia. First, we will verify the sensitivity of the image processing algorithm to
accurately quantify MBL in women with both normal and heavy menses (Specific Aim 1). Second, we will conduct
a pivotal clinical study to validate the effectiveness of eMBLD for diagnosing menorrhagia (Specific Aim 2). The
data obtained will support FDA 510(k) clearance and will allow us to commercialize the system within four years
of the funding of this proposal.
摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Daniel Rogers Burnett其他文献
Daniel Rogers Burnett的其他文献
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