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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03289468
Other study ID # XJTU1AF-CRF-2016T-14
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2017
Est. completion date December 30, 2019

Study information

Verified date September 2018
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Xiaofeng YANG, Doctor
Phone 0086-18602900810
Email yxf73@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The postmenopausal women with vaginal bleeding were selected in this cross-sectional study. The basic characteristics information and endometrial blood flow energy index of endometrium were detected by color power Doppler ultrasound, and the energy histogram of endometrium was obtained. The specimen of uterine cytology and endometrial tissue were obtained through minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical data were used to detect endometrial and precancerous lesions to observe the endpoint, and to provide the energy histogram model of the early warning endothelial diseases.


Description:

The postmenopausal women with vaginal bleeding are selected in this cross-sectional study. The uterine bleeding in patients with blood system diseases, reproductive organ outside the uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided into two groups(patients with endometrial benign diseases and patients with endometrial cancer and precancerous diseases) according to endometrial cytological and histological pathology. The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which were diagnosed by pathology.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers
Gender Female
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria:

- Postmenopausal women with vaginal bleeding

Exclusion Criteria:

- Vaginal bleeding caused by hematological system diseases or genitals outside the uterus

- Uterine bleeding caused by other organ cancers metastasize to the uterus

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler
The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology.

Locations

Country Name City State
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The endometrial vascularization index The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI). From March 2019 to December 2019
Secondary The ultrasonography of endometrium The ultrasonography of endometrium included shape, boundary and echo. From March 2019 to December 2019
Secondary The endometrial thickness The endometrial thickness in centimeter. From March 2019 to December 2019
Secondary The blood flow index of endometrium The blood flow index include peak systolic velocity(PSV),cm/s, end diastolic velocity(EDV) ,cm/s, mean flow velocity(MnV) ,cm/s, pulsatility index(PI), resistance index(RI). From March 2019 to December 2019
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