Adenomyosis of UterusNCT06751264
Evaluation of the Efficacy and Safety of Microwave Ablation of Uterine Adenomyosis Under Improved Ultrasound Guidance
A study testing Peritoneal combined with intrauterine water isolation and Peritoneal water isolation in people with Adenomyosis of Uterus, run by Peking University Aerospace Center Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Adenomyosis of Uterus
- What is being tested?
- Peritoneal combined with intrauterine water isolation and Peritoneal water isolation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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；
Who cannot join
- Pregnancy or malignancy；
- Severe and uncorrectable coagulation disorders；
- Severe cardiac, liver, and renal dysfunction；
- Anesthesia allergy.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the safety and efficacy of segmental power adjustment combined with uterine cavity hydro-isolation in microwave ablation of adenomyosis
- Conditions
- Adenomyosis of Uterus
- Being tested
- Peritoneal combined with intrauterine water isolation, Peritoneal water isolation
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal combined with intrauterine water isolationProcedure or 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 isolationProcedure or surgery
Transabdominal injection of saline into the abdominal cavity to achieve complete separation of the uterus from the surrounding organs and structures
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal water isolation | Experimental | Peritoneal water isolation Receives: Procedure: Peritoneal water isolation |
| Peritoneal combined with intrauterine water isolation | Experimental | Peritoneal combined with intrauterine water isolation Receives: Procedure: Peritoneal combined with intrauterine water isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of endometrial injury
Observe the differences in the rates of endometrial injury between two groups
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (2)
The reduction rate of adenomyosis volume
Observe the reduction rate of adenomyosis volume between two groups
Measured: From enrollment to the end of treatment at 1 year
complication
The complication rate between the two groups was compared
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomyosis of UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Lei, Peking University Aerospace Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751264
- Sponsor's protocol ID
- 2024-076
- Status last verified
- Jul 2026
- First submitted
- 13 Dec 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes