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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05569200
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Uterine Tumor	Device: Haifu Focused Ultrasound tumor therapeutic System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System.
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Haifu Focused Ultrasound tumor therapeutic System	Device: Haifu Focused Ultrasound tumor therapeutic System; 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.

Outcome Measures

Primary Outcome Measures

1. Evaluation of tumour response [3 month after treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Benign uterine fibroids.

2. Women over the age of 20.

3. Abdominal circumference <100 cm.

4. The largest fibroids are ≥ 4 cm.

Exclusion Criteria:

1. Pregnant women or those with positive pregnancy test results.

2. Those with other pelvic diseases.

3. Those with immune diseases.

4. There are unsuitable interfaces in the ultrasonic treatment path.

5. Those with tumor calcification.

6. People with severe heart, blood vessel and kidney disease.

7. Those with abnormal coagulation function and low platelets.

8. Type III fibroids according to Funaki classification

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05569200
• Other Study ID Numbers: 202111052RIPC
• First Posted: Oct 6, 2022
• Last Update Posted: Oct 6, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Uterine Neoplasms

Study Results

No Results Posted as of Oct 6, 2022