Large Algorithm Setting and Validation Study (LAVA)
A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.
The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.
研究概览
地位
详细说明
研究类型
注册 (估计的)
联系人和位置
学习地点
-
-
Florida
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North Miami、Florida、美国、33161
- 招聘中
- Segal Trials
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接触：
- Anna Kaplan
- 电话号码：347-678-6542
- 邮箱：akaplan@segaltrials.com
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首席研究员：
- Steven Chavoustie, MD, FACOG, CCRP
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Louisiana
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New Orleans、Louisiana、美国、70119
- 招聘中
- LSU-CrescentCare Sexual Health Center
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接触：
- Catherine Cammarata
- 电话号码：504-568-4132
- 邮箱：ccamma@lsuhsc.edu
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首席研究员：
- Rebecca Lillis, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:
- Abnormal vaginal discharge
- Vaginal or vulvar itching, burning, or irritation
- Painful or uncomfortable intercourse
- Vaginal odor
- Painful or frequent urination
Exclusion Criteria:
- Participants who do not meet the above-described inclusion criteria will be excluded from the study.
- Previously enrolled in this study
- Contraindication to vaginal swab sampling
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Vaginal Infections (BV, CV, TV)
|
Investigational Device
This is an FDA-cleared diagnostic test that will be used as labelled.
It will serve as one of three NAAT comparators in this study.
This is an FDA-cleared diagnostic test that will be used as labelled.
It will serve as one of three NAAT comparators in this study.
This is an FDA-cleared diagnostic test that will be used as labelled.
It will serve as one of three NAAT comparators in this study.
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections
大体时间：1 day
|
Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis
|
1 day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay
大体时间：1 day
|
Compare the performance between clinician-collected samples and self-collected samples using the Nanopath assay for diagnosing vaginitis.
|
1 day
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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