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Medical X-ray machine device for mammography

Medical X-ray machine device for mammography

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DCS-08000127
Enrollment
Unknown
Registered
2008-07-22
Start date
2008-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mammary diseases in females, including the localization diagnosis and the qualitative diagnosis of the hyperplasia of mammary glands,mammary mass or nodules, mammary calcification and mammary cancer.

Interventions

Gold Standard:
Index test:

Sponsors

Chengdu Kanghua Medical Science and Technology Co Ltd
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. women aged between 18 to 55 years old; 2. patients with mammary diseases or suspected patients, who have been diagnosed mammary mass by clinical test and mammary color ultrasound test, or uncertain mammary calcification who need mammary x_ray test to confirm the diagnosis; 3. attend the diagnostic test on their own wills, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. women with artificial breast; 2. pregnant or breast-feeding women; 3. patients who may have other dieases that are not suitabel to participate the test; 4. patients who had mammary disease or have received mammary operation on one side; 5. patients who have hemotological diseases or total WBC<4.0*10^9/L in blood examination.

Design outcomes

Primary

MeasureTime frame
Safety;Accuracy;Sensitivity;Negative predictive value;

Secondary

MeasureTime frame
Specificity;Positive predictive value;

Countries

China

Contacts

Public ContactGang Ning
ng6611@sina.com+86 028 85501339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026