Last updated: September 10, 2021
Sponsor: Limin Feng
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT04972032
E-IUS
Ages 18-40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female patients aged 18-40 years;
- Meets the diagnostic criteria for moderate to severe uterine adhesions;
- Has the indication for TCRA surgery and is intending to undergo TCRAsurgery;
- Female subjects are not breastfeeding at the time of the screeningvisit; ⑤ Voluntary acceptance of the treatment and has signed theinformed consent form.
Exclusion
Exclusion Criteria:
- Known allergic reactions to or contraindications for silicone rubber materials,estradiol and its metabolites, Foley balloon catheters and/or intrauterinecross-linked sodium hyaluronate gel;
- Presence of contraindications for TCRA surgery;
- Requires oral hormonal medications for a prolonged period of time;
- Has used high-dose estrogen medication within one month prior tosurgery;
- Suffering from diseases such as genital tract tuberculosis, acutegenital tract inflammation, pelvic inflammatory disease, abnormaluterine bleeding caused by systemic disease or malignant tumoursof the genital organs; ⑥ Perimenopausal and menopausal females; ⑦ Comorbid with severe primary diseases of the cardiovascular,cerebrovascular, hepatic, renal or hematopoietic system, or pepticulcer disease, or severe diseases affecting patient survival (suchas tumours or AIDS), or mental illness; ⑧ Drug or alcohol dependence; ⑨ Has enrolled in other clinical trials within the last 1 month; ⑩ Patients with factors considered by the investigators to beunsuitable for enrollment.
Study Design
Total Participants: 246
Study Start date:
September 02, 2020
Estimated Completion Date:
March 31, 2025
Study Description
Connect with a study center
YiPuRun (Shanghai) Biotechnology Co.,Ltd.
Shanghai, Shanghai
ChinaActive - Recruiting

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