Evaluation of the Efficacy and Safety of Microwave Ablation of Uterine Adenomyosis Under Improved Ultrasound Guidance

Not Applicable

Not yet recruiting

• Conditions: Adenomyosis of Uterus

• Registration Number: NCT06751264
• Lead Sponsor: Peking University Aerospace Centre Hospital

Brief Summary

This study aims to compare the safety and efficacy of segmental power adjustment combined with uterine cavity hydro-isolation in microwave ablation of adenomyosis

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 137

Inclusion Criteria

1. UFs or AM diagnosed by pathology and ultrasound；
2. Relevant symptoms such asabnormal uterine bleeding, secondary anemia, progressive dysmenorrhea and enlargement of the uterus；
3. Voluntarily undergo MWA；
4. a confirmed available safe transabdominal puncture path；

Exclusion Criteria

1. Pregnancy or malignancy；
2. Severe and uncorrectable coagulation disorders；
3. Severe cardiac, liver, and renal dysfunction；
4. Anesthesia allergy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The rates of endometrial injury	From enrollment to the end of treatment at 3 months	Observe the differences in the rates of endometrial injury between two groups

Secondary Outcome Measures

Name	Time	Method
The reduction rate of adenomyosis volume	From enrollment to the end of treatment at 1 year	Observe the reduction rate of adenomyosis volume between two groups
complication	From enrollment to the end of treatment at 1 year	The complication rate between the two groups was compared