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

Peking University Aerospace Centre Hospital

Status: Not yet enrolling

Conditions: Adenomyosis of Uterus

Treatments: Procedure: Peritoneal combined with intrauterine water isolation; Procedure: Peritoneal water isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT06751264

2024-076

Details and patient eligibility

About

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

Enrollment: 137 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Peritoneal water isolation

Experimental group

Description:

Peritoneal water isolation

Treatment:

Procedure: Peritoneal water isolation

Peritoneal combined with intrauterine water isolation

Experimental group

Description:

Peritoneal combined with intrauterine water isolation

Treatment:

Procedure: Peritoneal combined with intrauterine water isolation