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

ConditionAdenomyosis of Uterus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorPeking University Aerospace Center Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

Pregnancy or malignancy；

Severe and uncorrectable coagulation disorders；

Severe cardiac, liver, and renal dysfunction；

Anesthesia allergy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peritoneal combined with intrauterine water isolation

    Procedure/Surgery

    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/Surgery

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

Treatment groups

137 Participants
are divided into 2 treatment groups
Group A: Peritoneal water isolationExperimental treatment 1 intervention
Group B: Peritoneal combined with intrauterine water isolationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The rates of endometrial injury

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

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

Secondary outcomes

1

The reduction rate of adenomyosis volume

Observe the reduction rate of adenomyosis volume between two groups

Time frame
From enrollment to the end of treatment at 1 year
2

complication

The complication rate between the two groups was compared

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Aerospace Center Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: