Leiomyoma, UterineNCT05500118
Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
An observational study of Leiomyoma, Uterine and High-Intensity Focused Ultrasound Ablation, run by Shenzhen Maternity & Child Healthcare Hospital at 1 site in China.
Trial summary
With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Leiomyoma, Uterine, High-Intensity Focused Ultrasound Ablation, Patients Decision Aids
- What is being tested?
- Patients Decision Aids
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2022to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: 18-55 years old woman diagnosed with uterine fibroids and without clinical symptoms
Who may be able to join
- Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;
- Female with age in 18-55 years old;
- The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;
- No contraindications for sedation and analgesia;
- Patients and their families agree to join this study, and can follow up on time.
Who cannot join
- History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;
- History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;
- With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;
- The maximum diameter of leiomyoma is greater than or equal to 5cm;
- Suspected malignant tumor, such as sarcoma;
- Those with language communication barriers and unable to cooperate with sedative and analgesic programs;
- Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen Maternal and Child Health Hospital
Shenzhen, Guangdong, 518000
Ping Jin, Professor, 13925206896, 13925206896@163.com
About this study
With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.
- Being tested
- Patients Decision Aids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients Decision AidsOther
Patient Decision Aids (PDAs) are an important way to facilitate making decision by patients, helping patients make specific and prudent choices by providing information about treatment options and corresponding outcomes, including benefits and risks, related to their health status. The purpose of PDAs is to encourage patients to participate in decision-making. It makes it easier for patients and doctors to discuss treatment options. It effectively promotes communication between patients and doctors. It can help patients combine their own needs and professional advice to make better, more individualized diagnosis and treatment options.
| Study group | Role | What they receive |
|---|---|---|
| communication without PADs | We use traditional communication ways to discuss the conditions with patients. | |
| communication with PADs | The committee, composed of designers, doctors, nurses and patients, bases on guidelines and evidence-based medicine to make a tool. And we use this tool to discuss the conditions with patients. Receives: Other: Patients Decision Aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction after using PDAs
The patients in PDAs will undertake the treatment by PDAs. And we will collect the satisfaction after 12 months.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start31 Aug 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyoma, UterineStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Maternity & Child Healthcare Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Dai, Shenzhen Maternity & Child Healthcare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500118
- Sponsor's protocol ID
- 2021KFKT030
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
- ClinicalTrials.gov ID
- NCT05500118
- Acronym / sponsor ID
- 2021KFKT030
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenzhen Maternity & Child Healthcare HospitalUniversity, hospital or other
- Study start
- 31 Aug 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Aug 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.
With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| communication without PADs | – | –We use traditional communication ways to discuss the conditions with patients. |
| communication with PADs | – | Other: Patients Decision AidsThe committee, composed of designers, doctors, nurses and patients, bases on guidelines and evidence-based medicine to make a tool. And we use this tool to discuss the conditions with patients. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 18-55 years old woman diagnosed with uterine fibroids and without clinical symptoms
Key inclusion criteria (5 listed)
- Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;
- Female with age in 18-55 years old;
- The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;
- No contraindications for sedation and analgesia;
- Patients and their families agree to join this study, and can follow up on time.
Key exclusion criteria (7 listed)
- History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;
- History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;
- With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;
- The maximum diameter of leiomyoma is greater than or equal to 5cm;
- Suspected malignant tumor, such as sarcoma;
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 |
|---|---|---|
| Patients Decision AidsPatient Decision Aids (PDAs) are an important way to facilitate making decision by patients, helping patients make specific and prudent choices by providing information about treatment options and corresponding outcomes, including benefits and risks, related to their health status. The purpose of PDAs is to encourage patients to participate in decision-making. It makes it easier for patients and doctors to discuss treatment options. It effectively promotes communication between patients and doctors. It can help patients combine their own needs and professional advice to make better, more individualized diagnosis and treatment options. | Other | communication with PADs |
Primary outcome
Patient satisfaction after using PDAs
Time frame: 6-12 months
The patients in PDAs will undertake the treatment by PDAs. And we will collect the satisfaction after 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyoma, Uterine and High-Intensity Focused Ultrasound Ablation, run by Shenzhen Maternity & Child Healthcare Hospital at 1 site in China.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Aug 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Dai, Associate Professor (13828718985, daiyu829@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction after using PDAs (time frame: 6-12 months). 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 12 Aug 2022.