Obstetric/GynecologymyomaNCT05129956
Sonoguided-microwave Uterine Myoma
A study testing "Covidien" Emprint Ablation System with Thermosphere Technology in people with Obstetric/Gynecology, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study mainly evaluates the resolution of uterine fibroids by microwave ablation. The medical equipment used is Ke Hui. "The Ampening ablation system is a percutaneous surgery. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Obstetric/Gynecology
- What is being tested?
- "Covidien" Emprint Ablation System with Thermosphere Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Aug 2021to 31 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who have reached the age of 20 and have not yet menopause.
- Myoma size≧4cm.
- Patients with submucosal fmyoma or intramural myoma of the uterus.
Who cannot join
- Patients with subserosal myoma.
- Pregnant, breastfeeding or have menopause.
- Pelvic infections, vaginitis, cervicitis or endometritis and have not been cured.
- Malignant diseases of the cervix and uterus.
- Abnormal reports of clinical significance in Pap smear or thin-layer cell test.
- Abnormal blood coagulation function or liver and kidney function, with bleeding tendency.
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- There is no safe puncture treatment route.
- Those who have installed intrauterine contraceptive device or Pacemaker.
- Those who cannot perform vaginal ultrasound, such as those who have no sexual experience and do not accept hymen repair.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City
Cheng-Yu Long, Professor, +886-7-3121101 ext. 6428, urolong@yahoo.com.tw
Cheng-Yu Long, Professor
About this study
Official title: Efficacy Evaluation of Laparoscopic Sonoguided-microwave Uterine Myoma Ablation
This study mainly evaluates the resolution of uterine fibroids by microwave ablation. The medical equipment used is Ke Hui. "The Ampening ablation system is a percutaneous surgery. During laparoscopic surgery, it is directly ablated and soft, including problems that cannot be solved by partial or complete tissue ablation. "Hydrogen is used. If the expected range of ablation can be found, there is no need to wait for 3 to 6 months for ablation slowly like Haifu surgery. A fast, small, high-quality treatment that provides reference for medical treatment and helps doctors choose the most suitable treatment.
Read the detailed description
A collection of 20 women suffering from uterine fibroids were treated with microwave fibroids ablation for symptoms of uterine fibroids, and they could be discharged the next day or two days after surgery. Schedule return visits and routine blood tests according to clinical needs, and follow up with ultrasound and questionnaires during routine return visits (1, 3, and 6 months) after surgery. In the third month after surgery, there will be another imaging report. Magnetic resonance imaging and blood tests are used to compare the changes of patients' fibroids, their physiological recovery status, and the degree of improvement in their quality of life.
- Conditions
- Obstetric/Gynecology
- Being tested
- "Covidien" Emprint Ablation System with Thermosphere Technology
- Keywords
- microwave, uterine myoma
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Covidien" Emprint Ablation System with Thermosphere TechnologyDevice
Also called "Covidien" Emprint Percutaneous Antenna with Thermosphere Technology
The ablation time and wattage are determined according to the size of the tumor. The wattages are respectively 45W, 75W, and 100W, and the maximum time is 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| therapy group | Experimental | Not described Receives: Device: "Covidien" Emprint Ablation System with Thermosphere Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine myoma ablation
The ablation range of fibroids can be reduced by 50%, measured by MRI cubic centimeter volume.
Measured: 1 momth
Improve bleeding
The hemoglobin changes before and 3 months after the operation are used to evaluate the improvement of patients' bleeding problems.
Measured: 3 momths
Secondary outcomes (1)
Reduce days in hospital
Reduce the number of hospitalization days for patients to be less than or equal to 4 days.
Measured: 6 momths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start6 Aug 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric/GynecologyStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Yu Long, Professor, Principal investigator, Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129956
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210131
- Acronym
- myoma
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research results are clarified and then set and shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Laparoscopic Sonoguided-microwave Uterine Myoma Ablation
- ClinicalTrials.gov ID
- NCT05129956
- Acronym / sponsor ID
- myoma / KMUHIRB-F(I)-20210131
- Conditions
- Obstetric/Gynecology
- Keywords
- microwave, uterine myoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 2021 (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.
This study mainly evaluates the resolution of uterine fibroids by microwave ablation. The medical equipment used is Ke Hui. "The Ampening ablation system is a percutaneous surgery. During laparoscopic surgery, it is directly ablated and soft, including problems that cannot be solved by partial or complete tissue ablation. "Hydrogen is used. If the expected range of ablation can be found, there is no need to wait for 3 to 6 months for ablation slowly like Haifu surgery. A fast, small, high-quality treatment that provides reference for medical treatment and helps doctors choose the most suitable treatment.
Detailed description
A collection of 20 women suffering from uterine fibroids were treated with microwave fibroids ablation for symptoms of uterine fibroids, and they could be discharged the next day or two days after surgery. Schedule return visits and routine blood tests according to clinical needs, and follow up with ultrasound and questionnaires during routine return visits (1, 3, and 6 months) after surgery. In the third month after surgery, there will be another imaging report. Magnetic resonance imaging and blood tests are used to compare the changes of patients' fibroids, their physiological recovery status, and the degree of improvement in their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy group | Experimental | Device: "Covidien" Emprint Ablation System with Thermosphere Technology |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who have reached the age of 20 and have not yet menopause.
- Myoma size≧4cm.
- Patients with submucosal fmyoma or intramural myoma of the uterus.
Key exclusion criteria (9 listed)
- Patients with subserosal myoma.
- Pregnant, breastfeeding or have menopause.
- Pelvic infections, vaginitis, cervicitis or endometritis and have not been cured.
- Malignant diseases of the cervix and uterus.
- Abnormal reports of clinical significance in Pap smear or thin-layer cell test.
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 |
|---|---|---|
| "Covidien" Emprint Ablation System with Thermosphere TechnologyAlso: "Covidien" Emprint Percutaneous Antenna with Thermosphere TechnologyThe ablation time and wattage are determined according to the size of the tumor. The wattages are respectively 45W, 75W, and 100W, and the maximum time is 10 minutes | Device | therapy group |
Primary outcome
Uterine myoma ablation
Time frame: 1 momth
The ablation range of fibroids can be reduced by 50%, measured by MRI cubic centimeter volume.
Improve bleeding
Time frame: 3 momths
The hemoglobin changes before and 3 months after the operation are used to evaluate the improvement of patients' bleeding problems.
1 secondary outcome
Reduce days in hospital
Time frame: 6 momths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No. The research results are clarified and then set and shared.
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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.
Cheng-Yu Long, Professor principal investigator
Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Covidien" Emprint Ablation System with Thermosphere Technology in people with Obstetric/Gynecology, run by Kaohsiung Medical University Chung-Ho Memorial 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 3 inclusion and 9 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 22 Nov 2021. 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 Cheng-Yu Long, Professor (+886-7-3121101 ext. 6428, urolong@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine myoma ablation (time frame: 1 momth). The study lists 2 primary outcomes in all. 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 22 Nov 2021.