Uterine LeiomyomaNCT03328260
High Intensity Focused Ultrasound in Uterine Myoma
A study testing HIFU in people with Uterine Leiomyoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Uterine Leiomyoma
- What is being tested?
- HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2017to 30 Jun 2019
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal (FSH < 40 IU/L)
- Symptomatic uterine fibroids
- Willing to contracept during study period
Who cannot join
- Pregnant or willing to be pregnant in future
- Cancer in female reproductive organ is suspected or diagnosed
- Inflammation in female reproductive organ
- Poorly controlled systemic disease
- Hematocrit < 25%
- Glomerular filtration rate(GFR) <= 30ml/min
Show all 16Show fewer
- Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS)
- Cannot lie down
- Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks
- Cannot count the number or measure volume of leiomyoma using MRI
- Leiomyomas are inadequate (location, volume, number) for intervention
- Diameter of leiomyoma is over 5 cm
- Leiomyoma is not enhanced
- Lactating women
- Cannot communicate properly
- Participating or have participated in other trials within 30 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi DO, 463707
About this study
Official title: Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
- Conditions
- Uterine Leiomyoma
- Being tested
- HIFU
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUDevice
Transvaginal high intensity focused ultrasound to ablate uterine myoma
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non perfused volume
Non perfused volume in myoma immediately after ablation
Measured: treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start12 Dec 2017
- Primary completion31 Aug 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ALPINION Medical Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328260
- Sponsor's protocol ID
- APM-05
- Status last verified
- Dec 2019
- First submitted
- 29 Oct 2017
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JY, Kim K, Hwang SI, Lee M, Son K, Kim D, Kim S, Kim YB. Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:302-307. doi: 10.1016/j.ejogrb.2020.11.049. Epub 2020 Nov 17.
PubMed 33259999
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma
- ClinicalTrials.gov ID
- NCT03328260
- Acronym / sponsor ID
- APM-05
- Conditions
- Uterine Leiomyoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- ALPINION Medical Systems
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Nov 2017 (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.
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: HIFU |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Premenopausal (FSH < 40 IU/L)
- Symptomatic uterine fibroids
- Willing to contracept during study period
Key exclusion criteria (16 listed)
- Pregnant or willing to be pregnant in future
- Cancer in female reproductive organ is suspected or diagnosed
- Inflammation in female reproductive organ
- Poorly controlled systemic disease
- Hematocrit < 25%
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 |
|---|---|---|
| HIFUTransvaginal high intensity focused ultrasound to ablate uterine myoma | Device | Treatment |
Primary outcome
Non perfused volume
Time frame: treatment day
Non perfused volume in myoma immediately after ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Derived from this study: PubMed 33259999Lee JY, Kim K, Hwang SI, Lee M, Son K, Kim D, Kim S, Kim YB. Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:302-307. doi: 10.1016/j.ejogrb.2020.11.049. Epub 2020 Nov 17.
- Individual participant dataSharing planned: No
Related trials for Uterine Leiomyoma
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU in people with Uterine Leiomyoma, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 3 Jan 2020. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non perfused volume (time frame: treatment day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328260, which also lists 1 linked publication.
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 3 Jan 2020.