Benign Uterine TumorNCT05569200
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System
A study testing Haifu Focused Ultrasound tumor therapeutic System in people with Benign Uterine Tumor, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Benign Uterine Tumor
- What is being tested?
- Haifu Focused Ultrasound tumor therapeutic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign uterine fibroids.
- Women over the age of 20.
- Abdominal circumference <100 cm.
- The largest fibroids are ≥ 4 cm.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei
Kai-Wen Huang, +886-23123456 ext. 265915, fangyu0429@gmail.com
About this study
Official title: The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System.
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
- Being tested
- Haifu Focused Ultrasound tumor therapeutic System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haifu Focused Ultrasound tumor therapeutic SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Haifu Focused Ultrasound tumor therapeutic System | Experimental | Not described Receives: Device: Haifu Focused Ultrasound tumor therapeutic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tumour response
Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging
Measured: 3 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Uterine TumorStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569200
- Sponsor's protocol ID
- 202111052RIPC
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System.
- ClinicalTrials.gov ID
- NCT05569200
- Acronym / sponsor ID
- 202111052RIPC
- Conditions
- Benign Uterine Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haifu Focused Ultrasound tumor therapeutic System | Experimental | Device: Haifu Focused Ultrasound tumor therapeutic System |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Benign uterine fibroids.
- Women over the age of 20.
- Abdominal circumference <100 cm.
- The largest fibroids are ≥ 4 cm.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haifu Focused Ultrasound tumor therapeutic SystemThe 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. | Device | Haifu Focused Ultrasound tumor therapeutic System |
Primary outcome
Evaluation of tumour response
Time frame: 3 month after treatment
Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haifu Focused Ultrasound tumor therapeutic System in people with Benign Uterine Tumor, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Wen Huang, MD, PhD (+886-23123456 ext. 265915, fangyu0429@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of tumour response (time frame: 3 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.