The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System

NCT05569200 | Unknown

• 1 other identifier: 202111052RIPC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine benign tumor including myoma is the most common female benign pelvic tumor. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) has been considered to be a minimal invasive treatment. The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In this trial, the investigators will observe the possibility of complication and tumor response of treatment.

Conditions

Benign Uterine Tumor

Outcome Measures

Primary Outcomes (1)

• Evaluation of tumour response

  Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging

  3 month after treatment

Study Arms (1)

Haifu Focused Ultrasound tumor therapeutic System

EXPERIMENTAL

Device: Haifu Focused Ultrasound tumor therapeutic System

Interventions

Haifu Focused Ultrasound tumor therapeutic System DEVICE

The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In Uterine benign tumor female, the investigators will observe the possibility of complication and tumor response of treatment.

Haifu Focused Ultrasound tumor therapeutic System

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Benign uterine fibroids.
• Women over the age of 20.
• Abdominal circumference \<100 cm.
• The largest fibroids are ≥ 4 cm.

You may not qualify if:

• Pregnant women or those with positive pregnancy test results.
• Those with other pelvic diseases.
• Those with immune diseases.
• There are unsuitable interfaces in the ultrasonic treatment path.
• Those with tumor calcification.
• People with severe heart, blood vessel and kidney disease.
• Those with abnormal coagulation function and low platelets.
• Type III fibroids according to Funaki classification

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Central Study Contacts

Kai-Wen Huang, MD, PhD

CONTACT

+886-23123456; fangyu0429@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

TW (1)