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

NCT ID: NCT06751264

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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Conditions

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Adenomyosis of Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peritoneal water isolation

Peritoneal water isolation

Group Type EXPERIMENTAL

Peritoneal water isolation

Intervention Type PROCEDURE

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

Peritoneal combined with intrauterine water isolation

Peritoneal combined with intrauterine water isolation

Group Type EXPERIMENTAL

Peritoneal combined with intrauterine water isolation

Intervention Type 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.

Interventions

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Peritoneal 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.

Intervention Type PROCEDURE

Peritoneal water isolation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Aerospace Center Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liang Lei

Peking University Aerospace Centre Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Lei Liang, PHD

Role: CONTACT

Phone: 010-59971599

Email: [email protected]

Other Identifiers

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2024-076

Identifier Type: -

Identifier Source: org_study_id