Non-Puerperal MastitisNCT07894614
Ablation Versus Non-ablation Strategies for Non-puerperal Mastitis: A Prospective Real-world Registry Study
An observational study of Non-Puerperal Mastitis, run by Song Hongping at 1 site in China.
Trial summary
The goal of this prospective registry cohort study is to evaluate the efficacy and quality-of-life impact of ablation therapy in patients with non-puerperal mastitis. The main questions it aims to answer are: Does ablation therapy effectively control inflammation in patients with non-puerperal mastitis? Does ablation… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non-Puerperal Mastitis
- What is being tested?
- Ablation and Observation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2030
- How long will I take part?
- 2 Years
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This single-center study will prospectively enroll female patients aged 18 years or older with a pathologically confirmed diagnosis of non-puerperal mastitis via core needle biopsy at the First Affiliated Hospital of Air Force Medical University.
Who may be able to join
- Patients with non-puerperal mastitis confirmed by puncture or surgical pathology;
- Age ≥ 18 years;
- Voluntarily participate in this study and provide signed informed consent.
Who cannot join
- Pregnant or lactating women;
- Concurrent breast cancer;
- Severe hepatic or renal impairment (Definitions: Hepatic: ALT or AST > 2.5 × ULN, or total bilirubin > 2 × ULN, or Child-Pugh class B/C; Renal: eGFR < 30 mL/min/1.73 m², or requiring dialysis).
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
First Affiliated Hospital of Air Force Medical University
Xi'an, Shannxi, 710000
About this study
The goal of this prospective registry cohort study is to evaluate the efficacy and quality-of-life impact of ablation therapy in patients with non-puerperal mastitis. The main questions it aims to answer are:
Does ablation therapy effectively control inflammation in patients with non-puerperal mastitis?
Read more
Does ablation therapy lead to a superior quality of life compared to standard treatments?
Researchers will compare patients receiving ablation therapy to those receiving oral medication or surgery to see if ablation provides better inflammatory control and improves patients' quality of life.
Participants will undergo their assigned treatment (ablation, oral medication, or surgery) and be asked to complete regular follow-up visits and quality-of-life questionnaires over a long-term period.
Read the detailed description
Background: Non-puerperal mastitis is a chronic inflammatory breast disease with high recurrence rate. This single-center prospective observational cohort aims to compare clinical outcomes between ablation therapy and other real-world treatments for non-puerperal mastitis. Eligible female patients with pathologically-confirmed non-puerperal mastitis will receive clinical-decision-driven therapies including ablation, glucocorticoids, anti-tuberculosis agents, surgical resection or basic symptomatic care. All participants will be followed-up for 24 months. Clinical efficacy is evaluated by M-score; patient-reported quality of life is assessed using the BREAST-Q questionnaire. Stratified analyses will be performed to compare outcomes across different treatment groups.
- Conditions
- Non-Puerperal Mastitis
- Being tested
- Ablation, Observation
- Keywords
- Non-Puerperal Mastitis, prospective registry cohort study, quality of life, inflammation control, ablation therapy, non-ablation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Under real-time ultrasound guidance, an ablation needle (radiofrequency electrode, microwave antenna, or laser fiber) is precisely punctured into the center of the lesion. The corresponding energy generator is then connected with parameters configured, and energy delivery is initiated to rapidly raise local tissue temperature above 60 °C, inducing coagulative necrosis of cells via thermal biological effects. The ablation zone is continuously monitored by imaging during the procedure; needle position or parameters are adjusted when necessary to ensure complete lesion coverage. Energy output is terminated once the pre-set ablation margin is achieved, and the ablation needle is withdrawn.
ObservationOther
Also called drug, surgery
Basic symptomatic treatment: Patients receive symptomatic care. Glucocorticoid therapy: Prednisone (5 mg), methylprednisolone (4 mg) or prednisone acetate (5 mg) starts at 0.5 mg/(kg·d). After 2-week maintenance, doses are gradually tapered; low-dose maintenance (2.5-5.0 mg/d) continues 4-8 weeks per symptoms and tolerability.
Anti-tuberculosis therapy: Oral rifampicin, isoniazid and ethambutol for 6-9 months.
Surgical resection: Pre-operative ultrasound maps lesions. Local or general anesthesia is used. Inflammatory lesions and sinus tracts are completely excised with maximal preservation of normal breast parenchyma.Intra-operative hemostasis and saline irrigation are done; primary closure or open drainage depends on wound status. Post-operative symptomatic care and wound dressing are provided.
| Study group | Role | What they receive |
|---|---|---|
| Ablation Group | Patients receiving ablation therapy for non-puerperal mastitis. Receives: Procedure: Ablation | |
| Non-ablation group | Patients receiving treatments other than ablation therapy include glucocorticoid therapy, anti-tuberculosis therapy, surgical resection and basic symptomatic treatment. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year complete remission
Complete disappearance of clinical symptoms and complete resolution of target lesions on imaging evaluation within 1 year.
Measured: From enrollment up to 1 year post-treatment completion
Secondary outcomes (8)
Time to Complete Remission
Complete disappearance of clinical symptoms and complete resolution of target lesions on imaging evaluation.
Measured: From enrollment up to 1 year post-treatment completion
1-Year Partial Response
Improvement in all clinically significant symptoms, including pain, swelling, erythema, and induration, within 1 year; OR at least a 30% decrease in the sum of target lesion diameters relative to the baseline sum.
Measured: From enrollment up to 1 year post-treatment completion
1-Year Overall Response
Achieving either complete remission (CR) or partial remission (PR) criteria within 1 year.
Measured: From enrollment up to 1 year post-treatment completion
Non-Response
Target lesion shrinkage is insufficient to meet PR criteria, or disease progression, new ulceration, or fistula formation occurs during treatment.
Measured: From enrollment up to 1 year post-treatment completion
Recurrence Rate
Disease recurrence 3 months after achieving clinical and ultrasound-confirmed complete remission.
Measured: From enrollment up to 3 month post-treatment completion
Time to Recurrence
Disease recurrence 3 months after achieving clinical and ultrasound-confirmed complete remission.
Measured: From enrollment up to 3 month post-treatment completion
M-SCORE
a clinical severity scoring system for non-puerperal mastitis, consisting of mass, erythema, pain, fistula and abscess subscores. Higher scores indicate more severe disease.
Measured: From enrollment up to 1 year post-treatment completion
Breast satisfaction (BREAST-Q score)
a validated patient-reported outcome questionnaire to assess breast satisfaction, psychosocial well-being, physical well-being and sexual well-being. Scores range from 0 to 100; higher scores indicate better patient-reported outcomes.
Measured: From enrollment up to 1 year post-treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Jan 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Puerperal MastitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Song Hongping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Song Hongping, The First Affiliated Hospital of the Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894614
- Sponsor's protocol ID
- XJYYNPMABL202605
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation Versus Non-ablation Strategies for Non-puerperal Mastitis: A Prospective Real-world Registry Study
- ClinicalTrials.gov ID
- NCT07894614
- Acronym / sponsor ID
- XJYYNPMABL202605
- Conditions
- Non-Puerperal Mastitis
- Keywords
- Non-Puerperal Mastitis, prospective registry cohort study, quality of life, inflammation control, ablation therapy, non-ablation therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Song HongpingUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 26 Oct 2026 (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.
The goal of this prospective registry cohort study is to evaluate the efficacy and quality-of-life impact of ablation therapy in patients with non-puerperal mastitis. The main questions it aims to answer are:
Does ablation therapy effectively control inflammation in patients with non-puerperal mastitis?
Does ablation therapy lead to a superior quality of life compared to standard treatments?
Researchers will compare patients receiving ablation therapy to those receiving oral medication or surgery to see if ablation provides better inflammatory control and improves patients' quality of life.
Participants will undergo their assigned treatment (ablation, oral medication, or surgery) and be asked to complete regular follow-up visits and quality-of-life questionnaires over a long-term period.
Detailed description
Background: Non-puerperal mastitis is a chronic inflammatory breast disease with high recurrence rate. This single-center prospective observational cohort aims to compare clinical outcomes between ablation therapy and other real-world treatments for non-puerperal mastitis. Eligible female patients with pathologically-confirmed non-puerperal mastitis will receive clinical-decision-driven therapies including ablation, glucocorticoids, anti-tuberculosis agents, surgical resection or basic symptomatic care. All participants will be followed-up for 24 months. Clinical efficacy is evaluated by M-score; patient-reported quality of life is assessed using the BREAST-Q questionnaire. Stratified analyses will be performed to compare outcomes across different treatment groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation Group | – | Procedure: AblationPatients receiving ablation therapy for non-puerperal mastitis. |
| Non-ablation group | – | Other: ObservationPatients receiving treatments other than ablation therapy include glucocorticoid therapy, anti-tuberculosis therapy, surgical resection and basic symptomatic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This single-center study will prospectively enroll female patients aged 18 years or older with a pathologically confirmed diagnosis of non-puerperal mastitis via core needle biopsy at the First Affiliated Hospital of Air Force Medical University.
Key inclusion criteria (3 listed)
- Patients with non-puerperal mastitis confirmed by puncture or surgical pathology;
- Age ≥ 18 years;
- Voluntarily participate in this study and provide signed informed consent.
Key exclusion criteria (3 listed)
- Pregnant or lactating women;
- Concurrent breast cancer;
- Severe hepatic or renal impairment (Definitions: Hepatic: ALT or AST > 2.5 × ULN, or total bilirubin > 2 × ULN, or Child-Pugh class B/C; Renal: eGFR < 30 mL/min/1.73 m², or requiring dialysis).
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 |
|---|---|---|
| AblationUnder real-time ultrasound guidance, an ablation needle (radiofrequency electrode, microwave antenna, or laser fiber) is precisely punctured into the center of the lesion. The corresponding energy generator is then connected with parameters configured, and energy delivery is initiated to rapidly raise local tissue temperature above 60 °C, inducing coagulative necrosis of cells via thermal biological effects. The ablation zone is continuously monitored by imaging during the procedure; needle position or parameters are adjusted when necessary to ensure complete lesion coverage. Energy output is terminated once the pre-set ablation margin is achieved, and the ablation needle is withdrawn. | Procedure or surgery | Ablation Group |
| ObservationAlso: drug, surgeryBasic symptomatic treatment: Patients receive symptomatic care. Glucocorticoid therapy: Prednisone (5 mg), methylprednisolone (4 mg) or prednisone acetate (5 mg) starts at 0.5 mg/(kg·d). After 2-week maintenance, doses are gradually tapered; low-dose maintenance (2.5-5.0 mg/d) continues 4-8 weeks per symptoms and tolerability. Anti-tuberculosis therapy: Oral rifampicin, isoniazid and ethambutol for 6-9 months. Surgical resection: Pre-operative ultrasound maps lesions. Local or general anesthesia is used. Inflammatory lesions and sinus tracts are completely excised with maximal preservation of normal breast parenchyma.Intra-operative hemostasis and saline irrigation are done; primary closure or open drainage depends on wound status. Post-operative symptomatic care and wound dressing are provided. | Other | Non-ablation group |
Primary outcome
1-year complete remission
Time frame: From enrollment up to 1 year post-treatment completion
Complete disappearance of clinical symptoms and complete resolution of target lesions on imaging evaluation within 1 year.
8 secondary outcomes
Time to Complete Remission
Time frame: From enrollment up to 1 year post-treatment completion
1-Year Partial Response
Time frame: From enrollment up to 1 year post-treatment completion
1-Year Overall Response
Time frame: From enrollment up to 1 year post-treatment completion
Non-Response
Time frame: From enrollment up to 1 year post-treatment completion
Recurrence Rate
Time frame: From enrollment up to 3 month post-treatment completion
Time to Recurrence
Time frame: From enrollment up to 3 month post-treatment completion
M-SCORE
Time frame: From enrollment up to 1 year post-treatment completion
Breast satisfaction (BREAST-Q score)
Time frame: From enrollment up to 1 year post-treatment completion
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 26 Oct 2026.
- 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 Non-Puerperal Mastitis, run by Song Hongping 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 3 inclusion and 3 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 26 Oct 2026. 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 Hongping Song, Principal Investigator (+8613991802810, song.hp@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year complete remission (time frame: From enrollment up to 1 year post-treatment completion). 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 26 Oct 2026.