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Feasibility study of Li-brush endometrial cell sampler for screening endometrial lesions in IUD patients

Feasibility study of Li-brush endometrial cell sampler for screening endometrial lesions in IUD patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020123
Enrollment
Unknown
Registered
2018-12-15
Start date
2019-01-01
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Endometrial Cancer

Interventions

Gold Standard:1)Endometrial tissue pathological results obtained after curettage
2) Pathological results of endometrial tissue obtained after total hysterectomy.
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Li-brush

Sponsors

First Affiliated Hospital, Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Group A: 1) Childbearing age, vaginal bleeding after the use of IUD, the amount is small, there are still contraceptive needs; 2) B-ultrasound suggests that the intima thickening is uneven or sputum, no abnormal bleeding, IUD patients who need to exclude endometrial lesions, such as long-term oral tamoxifen after breast cancer surgery; 3) Mirena treatment of endometrial atypical hyperplasia or endometrial hyperplasia, requiring regular review; 4) Place the IUD in the uterus and ask for screening for endometrial lesions. Group B: 1) Abnormal uterine bleeding requires IUD patients who have been diagnosed and stopped by surgery; 2) Postmenopausal vaginal bleeding requires removal of the ring and the diagnosis of IUD patients with lesions. 2. 1) Patients undergoing diagnostic curettage; 2) Patients undergoing total hysterectomy. 3. 1) Patients undergoing diagnostic curettage; 2) Patients undergoing total hysterectomy. 4. 1) Patients undergoing diagnostic curettage; 2) Patients undergoing total hysterectomy.

Exclusion criteria

Exclusion criteria: 1. 1) acute inflammation of the reproductive system (except atrophic vaginitis); 2) endogenous cervical cancer; 3) abnormal blood coagulation and other blood system diseases that affect blood coagulation; 4) Pregnancy or suspected pregnancy; 5) The amount of bleeding is large, and it is necessary to urgently cure and stop bleeding; 6) Highly suspected that the IUD is displaced, even causing uterus and cervical perforation; 7) Peri-menopause, it is recommended to take out the IUD. 8) Women of childbearing age who have a pregnancy request and request to take out the IUD; 9) Those who have a body temperature exceeding 37.5 °C on the day of the visit. 2. 1) Acute inflammation of the reproductive system (except atrophic vaginitis); 2) Endogenous cervical cancer; 3) Abnormal blood coagulation function and other blood system diseases that affect blood coagulation; 4) Those who have a large amount of bleeding and need urgent diagnosis and curettage; 5) Those whose body temperature exceeds 37.5? twice on the day of treatment. 3. 1) Acute inflammation of the reproductive system (except atrophic vaginitis); 2) Endogenous cervical cancer; 3) Abnormal blood coagulation function and other blood system diseases that affect blood coagulation; 4) Those who have a large amount of bleeding and need urgent diagnosis and curettage; 5) Those whose body temperature exceeds 37.5? twice on the day of treatment. 4. 1)Cervical cancer, ovarian cancer, peritoneal cancer; 2)acute severe systemic disease 3)acute inflammation of the reproductive system (except atrophic vaginitis); 4)abnormal blood coagulation function and other blood system diseases that affect blood coagulation; 5) Those who have a large amount of bleeding and need urgent diagnosis and curettage; 6) Those whose body temperature exceeds 37.5? twice on the day of treatment.

Design outcomes

Primary

MeasureTime frame
the cytopathologic diagnosis ;IUD upper edge distance from the fundus serosa;the histopathologic diagnosis;

Secondary

MeasureTime frame
the histopathologic diagnosis ;

Countries

China

Contacts

Public ContactLu Han

First Affiliated Hospital, Xi'an Jiaotong University

657483525@qq.com+86 13609260445

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026