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

NCT06751264 | Not Yet Recruiting DMC

• 1 other identifier: 2024-076
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

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

Conditions

Adenomyosis of Uterus

Outcome Measures

Primary Outcomes (1)

• The rates of endometrial injury

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

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (2)

• The reduction rate of adenomyosis volume

  From enrollment to the end of treatment at 1 year

• complication

  From enrollment to the end of treatment at 1 year

Study Arms (2)

Peritoneal water isolation

EXPERIMENTAL

Peritoneal water isolation

Procedure: Peritoneal water isolation

Peritoneal combined with intrauterine water isolation

EXPERIMENTAL

Peritoneal combined with intrauterine water isolation

Procedure: Peritoneal combined with intrauterine water isolation

Interventions

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 combined with intrauterine water isolation

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

Peritoneal water isolation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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；

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Aerospace Center Hospital: lead

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Lei Liang, PHD

CONTACT

010-59971599; lianglei_csk@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University Aerospace Centre Hospital

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR