Nipple DischargeNCT07305558
Microdochectomy for Chronic Non Dilated Single Duct Nipple Discharge
A study testing ultrasound guided microdochectomy in people with Nipple Discharge, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of a new technique in treatment of single milk duct discharge. The main questions it aims to answer are: Does ultrasound guided microdochectomy is feasible in non dilated milk duct? What are the surgical outcomes of this technique? Participants will: Had… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nipple Discharge
- What is being tested?
- ultrasound guided microdochectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2025to 27 Apr 2026
- Phase
- Interventional
- 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
Who may be able to join
- females above 18 years old with single not dilated milk duct discharge after failure of medical treatment
Who cannot join
- breast cancer
- patients with multiple or dilated milk duct discharge.
- contraindications to surgery or anaesthesia
- patient above 18 years old
- patients refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Microdochectomy in Chronic Non Dilated Single Duct Nipple Discharge
The goal of this clinical trial is to evaluate the efficacy of a new technique in treatment of single milk duct discharge. The main questions it aims to answer are:
Does ultrasound guided microdochectomy is feasible in non dilated milk duct? What are the surgical outcomes of this technique?
Participants will:
Had ultrasound microdochectomy After discharge, patients will visit the clinic twice every week for two weeks, a visit or call after 3 month
- Conditions
- Nipple Discharge
- Being tested
- ultrasound guided microdochectomy
- Keywords
- nipple discharge, microdochectomy, breast
- Medical subject headings
- Galactorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided microdochectomyProcedure or surgery
ultrasound was used to perform microdochectomy for single not dilated milk duct without cannulation
| Study group | Role | What they receive |
|---|---|---|
| patients with single milk duct discharge | Experimental | Not described Receives: Procedure: ultrasound guided microdochectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple discharge
stop of spontaneous and induced nipple discharge by absence of stain on dressing and clothes and by squeezing the nipple
Measured: from first day after surgery to 3 months after surgery
Secondary outcomes (5)
operation time
operation time is calculated in minutes
Measured: from skin incision to closure
Bleeding
Bleeding is evaluated in mm using gravimetric and direct vision methods
Measured: from skin incision to skin closure
post operative pain
post operative pain is assessed using the visual analogue scale. The total score is out of 10 (1 means painless, 10 means painful)
Measured: from the day of surgery to one week after surgery
hospital stay
hospital stay is recorded in days
Measured: from the first day of surgery to 3 days after surgery
wound infection
wound infection diagnosed by direct vision of pus or ultrasound of the breast
Measured: from one day to 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start27 Apr 2025
- Primary completion27 Apr 2026 (estimated)
- Study completion27 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipple DischargeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
- Investigators
- Reham Zakaria, M.D, Principal investigator, faculty of medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305558
- Sponsor's protocol ID
- 1248\27-4-2025
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be available on demand by direct contact to the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Microdochectomy in Chronic Non Dilated Single Duct Nipple Discharge
- ClinicalTrials.gov ID
- NCT07305558
- Acronym / sponsor ID
- 1248\27-4-2025
- Conditions
- Nipple Discharge
- Keywords
- nipple discharge, microdochectomy, breast
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 27 Apr 2026 (estimated)
- Study completion
- 27 Apr 2026 (estimated)
- First posted
- 26 Dec 2025 (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 clinical trial is to evaluate the efficacy of a new technique in treatment of single milk duct discharge. The main questions it aims to answer are:
Does ultrasound guided microdochectomy is feasible in non dilated milk duct? What are the surgical outcomes of this technique?
Participants will:
Had ultrasound microdochectomy After discharge, patients will visit the clinic twice every week for two weeks, a visit or call after 3 month
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with single milk duct discharge | Experimental | Procedure: ultrasound guided microdochectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- females above 18 years old with single not dilated milk duct discharge after failure of medical treatment
Key exclusion criteria (5 listed)
- breast cancer
- patients with multiple or dilated milk duct discharge.
- contraindications to surgery or anaesthesia
- patient above 18 years old
- patients refuse to participate in the study
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 |
|---|---|---|
| ultrasound guided microdochectomyultrasound was used to perform microdochectomy for single not dilated milk duct without cannulation | Procedure or surgery | patients with single milk duct discharge |
Primary outcome
Nipple discharge
Time frame: from first day after surgery to 3 months after surgery
stop of spontaneous and induced nipple discharge by absence of stain on dressing and clothes and by squeezing the nipple
5 secondary outcomes
operation time
Time frame: from skin incision to closure
Bleeding
Time frame: from skin incision to skin closure
post operative pain
Time frame: from the day of surgery to one week after surgery
hospital stay
Time frame: from the first day of surgery to 3 days after surgery
wound infection
Time frame: from one day to 2 weeks after surgery
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 Dec 2025.
- Individual participant dataSharing planned: Undecided. data will be available on demand by direct contact to the principle investigator
Related trials for Nipple Discharge
Active, not recruitingObservational study
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
Mammary Tumor, Nipple Discharge
Active, not recruiting
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Mammary Tumor, Nipple Discharge
Active, not recruiting
Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge
Breast Carcinoma
RecruitingObservational study
A Study on Combined Low-pass Whole-genome and Methylome Testing of Bloody Nipple Discharge Specimens for Benign-Malignant Differentiation.
Breast Cancer, Nipple Discharge
Recruiting
Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
Breast Cancer, Mastectomy
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.
Reham Zakaria, M.D principal investigator
faculty of medicine, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided microdochectomy in people with Nipple Discharge, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. 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 Egypt. 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?
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?
Nipple discharge (time frame: from first day after surgery to 3 months after surgery). 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 Dec 2025.