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

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

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Key information

Conditions

Adenomyosis of Uterus Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Peritoneal combined with intrauterine water isolation

Procedure

On the basis of the conventional peritoneal water isolation group, the improved technology group added additional intrauterine water isolation, and continued to inject ice saline to separate the endometrium on both sides.

Peritoneal water isolation

Procedure

Transabdominal injection of saline into the abdominal cavity to achieve complete separation of the uterus from the surrounding organs and structures

Primary outcomes

The rates of endometrial injury

Time frame: From enrollment to the end of treatment at 3 months

Observe the differences in the rates of endometrial injury between two groups

Secondary outcomes

The reduction rate of adenomyosis volume

Time frame: From enrollment to the end of treatment at 1 year

Observe the reduction rate of adenomyosis volume between two groups
complication

Time frame: From enrollment to the end of treatment at 1 year

The complication rate between the two groups was compared

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Liang, PHD

CONTACT

[email protected]

010-59971599

Sponsors and collaborators

Lead sponsor

Peking University Aerospace Center Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Dec 27, 2024
Registry last updated: Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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