A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system.

A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system.
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DOI:
10.1038/s41598-020-72219-9
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发表时间:
2020-10-06
期刊:
影响因子:
4.6
通讯作者:
Ramanujam N
Ramanujam N
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Asiedu MN;Agudogo JS;Dotson ME;Skerrett E;Krieger MS;Lam CT;Agyei D;Amewu J;Asah-Opoku K;Huchko M;Schmitt JW;Samba A;Srofenyoh E;Ramanujam N

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对窥镜的恐惧和妇科检查期间的脆弱感是妇女进行宫颈癌筛查的两个最大障碍。为了解决这些障碍,我们开发了一种称为Callascope的新型低成本工具,以重新构想妇科检查,使临床医生能够在不需要窥镜的情况下对宫颈进行自我成像。Callascope包含一个200万像素的摄像头和造影剂喷射机构,其外形设计旨在消除造影剂给药和图像捕获期间对窥镜的需求。初步的台架测试比较的Callascope相机,以20,000美元的高端阴道镜表明,Callascope相机满足视觉要求的宫颈成像。喷雾机制的台架测试表明,造影剂输送能够实现令人满意的给药和宫颈覆盖。在杜克大学医学中心(达勒姆,美国)和大阿克拉地区医院(阿克拉,加纳)进行的临床研究评估了(1)与标准护理窥器检查相比,Callascope显示宫颈的能力,(2)女性使用Callascope进行自我检查的可行性和意愿,以及(3)临床医生及其患者使用Callascope进行基于临床医生的检查的可行性和意愿。当由临床医生进行时,Callascope和窥器之间的宫颈可视化相当(83%或44/53例女性vs. 100%)。在使用Callascope进行自我成像的女性中,95%(21/22)实现了可视化。检查后的调查表明,参与者更喜欢Callascope的一个speculum为基础的exam. Our结果表明,Callascope是一个可行的选择,为临床医生为基础的和自我检查speculum自由宫颈成像。临床研究注册ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/record/ NCT 00900575,泛非临床试验注册中心(PACTR)https://www.pactr.org/ PACTR 201905806116817。
Fear of the speculum and feelings of vulnerability during the gynecologic exams are two of the biggest barriers to cervical cancer screening for women. To address these barriers, we have developed a novel, low-cost tool called the Callascope to reimagine the gynecological exam, enabling clinician and self-imaging of the cervix without the need for a speculum. The Callascope contains a 2 megapixel camera and contrast agent spray mechanism housed within a form factor designed to eliminate the need for a speculum during contrast agent administration and image capture. Preliminary bench testing for comparison of the Callascope camera to a $20,000 high-end colposcope demonstrated that the Callascope camera meets visual requirements for cervical imaging. Bench testing of the spray mechanism demonstrates that the contrast agent delivery enables satisfactory administration and cervix coverage. Clinical studies performed at Duke University Medical Center, Durham, USA and in Greater Accra Regional Hospital, Accra, Ghana assessed (1) the Callascope’s ability to visualize the cervix compared to the standard-of-care speculum exam, (2) the feasibility and willingness of women to use the Callascope for self-exams, and (3) the feasibility and willingness of clinicians and their patients to use the Callascope for clinician-based examinations. Cervix visualization was comparable between the Callascope and speculum (83% or 44/53 women vs. 100%) when performed by a clinician. Visualization was achieved in 95% (21/22) of women who used the Callascope for self-imaging. Post-exam surveys indicated that participants preferred the Callascope to a speculum-based exam. Our results indicate the Callascope is a viable option for clinician-based and self-exam speculum-free cervical imaging. Clinical study registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/record/ NCT00900575, Pan African Clinical Trial Registry (PACTR) https://www.pactr.org/ PACTR201905806116817.
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期刊: PLOS ONE
影响因子: 3.7
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发表时间: 1999-11-01
影响因子: 6.4
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