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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06751264
Enrollment
137
Registered
2024-12-27
Start date
2025-01-20
Completion date
2027-12-31
Last updated
2026-08-03

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

Conditions

Adenomyosis of Uterus

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

Interventions

PROCEDUREPeritoneal combined with intrauterine water isolation

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.

PROCEDUREPeritoneal water isolation

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

Sponsors

Peking University Aerospace Center Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rates of endometrial injuryFrom enrollment to the end of treatment at 3 monthsObserve the differences in the rates of endometrial injury between two groups

Secondary

MeasureTime frameDescription
The reduction rate of adenomyosis volumeFrom enrollment to the end of treatment at 1 yearObserve the reduction rate of adenomyosis volume between two groups
complicationFrom enrollment to the end of treatment at 1 yearThe complication rate between the two groups was compared

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026