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Exploring the application value of three-dimensional contrast-enhanced ultrasound combined with VOCAL technology in the evaluation of ablation efficacy for benign uterine lesions

Exploring the application value of three-dimensional contrast-enhanced ultrasound combined with VOCAL technology in evaluating the ablation efficacy of focal adenomyosis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092702
Enrollment
Unknown
Registered
2024-11-21
Start date
2023-09-04
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Adenomyosis of uterus

Interventions

Gold Standard:3D-CEMRI
Index test:Preoperative lesion volume
Volume of non perfused area 1 day and 3 months after surgery
Volume of lesion at 3 months, 6 months, and 1 year after surgery

Sponsors

Longyan First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
23 Years to 53 Years

Inclusion criteria

Inclusion criteria: 1. Having AM related symptoms; 2. Patients with localized AM diagnosed by ultrasound and MRI; 3. Ineffective or aggravated by medication or other conservative treatment; 4. Strongly hope to preserve the uterus and voluntarily undergo ablation treatment; 5. Having a safe puncture path through the abdominal wall;

Exclusion criteria

Exclusion criteria: 1. Menstruation, pregnancy, or lactation; 2. Cervical intraepithelial neoplasia with CNI grade III or above; 3. Severe atypical hyperplasia of the endometrium; 4. Uncontrolled acute pelvic inflammatory disease; 5. There are contraindications for ultrasound and MRI examination; 6. Severe heart, lung, liver, kidney dysfunction, malignant tumors or hematological diseases; 7. There is no safe percutaneous puncture pathway; 8. Severe coagulation dysfunction.

Design outcomes

Primary

MeasureTime frame
Preoperative lesion volume;non-perfused volume;Residual lesion;

Secondary

MeasureTime frame
Uterine Fibroid Symptom and Quality of Life scores;VAS dysmenorrhea score;menstrual volume scores;

Countries

China

Contacts

Public ContactLin min

Longyan First Affiliated Hospital of Fujian Medical University

269129376@qq.com+86 183 5918 6280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026