GynecomastiaNCT07353411
To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males
A study testing Single-port Robotic-assisted Subcutaneous Gland Resection in males in people with Gynecomastia, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. Read more about this study
- Who is it for?
- Ages 17 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecomastia
- What is being tested?
- Single-port Robotic-assisted Subcutaneous Gland Resection in males
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Nov 2028
- 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 17 to 75 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male patients, aged 18-75 years old;
- Preoperative breast ultrasound indicates male breast development, and breast enlargement symptoms persist for more than 1 year;
- Primary male breast development that has been unresponsive to drug treatment, or those who refuse drug treatment;
- According to Gynecomastia's surgical indications, refer to the "2023 Expert consensus on the clinicaldiagnosis and treatment of gynecomastia in China" Simon grading of male breast development IIb or above;
- Due to social pressure or severe psychological burden caused by symptoms such as breast pain, those who have a strong desire for surgery may experience psychological burden caused by the disease and actively request surgery;
- Individuals without serious accompanying diseases;
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- Suspected malignant transformation;
- No other serious underlying diseases in the past;
- The surgical procedure includes a single hole robot (intraperitoneal endoscopic single hole surgical system SP1000) for subcutaneous gland resection of the breast;
- Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up;
- No swallowing difficulties; No shoulder joint movement disorders;
- Complete clinical data.
Who cannot join
- Age<16 years old, still in puberty, or disease duration ≤ 1 year;
- Simple obesity, no obvious glandular tissue was found on breast ultrasound examination;
- Male patients with breast developmental disorders secondary to other diseases;
- Patients with contraindications for general anesthesia surgery such as coagulation dysfunction and severe cardiovascular disease, who cannot tolerate surgery;
- The clinical data is basically incomplete;
- Other surgical methods;
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- Individuals with a history of breast surgery or breast tumors in the past;
- The serious diseases of non malignant tumors such as congenital testicular hypoplasia syndrome, cirrhosis, primary hypogonadism, and hyperthyroidism will affect the patient's compliance or put the patient in a dangerous state;
- Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms;
- Lack of trust in surgical outcomes and weak desire for surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection in the treatment of gynecomastia.
Read the detailed description
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection in the treatment of gynecomastia.
- Conditions
- Gynecomastia
- Being tested
- Single-port Robotic-assisted Subcutaneous Gland Resection in males
- Keywords
- Single-port Robotic-assisted subcutaneous gland resection
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port Robotic-assisted Subcutaneous Gland Resection in malesProcedure or surgery
Single-port Robotic-assisted Subcutaneous Gland Resection for males in the treatment of gynecomastia.
| Study group | Role | What they receive |
|---|---|---|
| the single-port robotic-assisted subcutaneous gland resection group | Experimental | the single-port robotic-assisted subcutaneous gland resection in the management of gynecomastia Receives: Procedure: Single-port Robotic-assisted Subcutaneous Gland Resection in males |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's and doctor's satisfaction
Use the Health Status Survey Questionnaire (SF-36) to assess the general condition of patients.
Measured: 2 years
Patient's psychological status using the Self Rating Anxiety Scale (SAS)
Use the Self Rating Anxiety Scale (SAS) to assess the psychological status of patients.
Measured: 2 years
Patient's psychological status
Use the Self Rating Depression Scale (SDS) to assess the psychological status of patients.
Measured: 2 years
Patient's sensory
Using Semmes Weinstein (S-W) monofilament to detect postoperative sensory recovery in patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Model description
- Single-port Robotic-assisted Subcutaneous Gland Resection for males in the treatment of gynecomastia.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353411
- Sponsor's protocol ID
- DQ-GYN-Robot-20251010
- Status last verified
- Oct 2025
- First submitted
- 11 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males
- ClinicalTrials.gov ID
- NCT07353411
- Acronym / sponsor ID
- DQ-GYN-Robot-20251010
- Conditions
- Gynecomastia
- Keywords
- Single-port Robotic-assisted subcutaneous gland resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 20 Jan 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 new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection in the treatment of gynecomastia.
Detailed description
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection in the treatment of gynecomastia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-port Robotic-assisted Subcutaneous Gland Resection for males in the treatment of gynecomastia.
| Arm | Type | Receives |
|---|---|---|
| the single-port robotic-assisted subcutaneous gland resection group | Experimental | Procedure: Single-port Robotic-assisted Subcutaneous Gland Resection in malesthe single-port robotic-assisted subcutaneous gland resection in the management of gynecomastia |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Male patients, aged 18-75 years old;
- Preoperative breast ultrasound indicates male breast development, and breast enlargement symptoms persist for more than 1 year;
- Primary male breast development that has been unresponsive to drug treatment, or those who refuse drug treatment;
- According to Gynecomastia's surgical indications, refer to the "2023 Expert consensus on the clinicaldiagnosis and treatment of gynecomastia in China" Simon grading of male breast development IIb or above;
- Due to social pressure or severe psychological burden caused by symptoms such as breast pain, those who have a strong desire for surgery may experience psychological burden caused by the disease and actively request surgery;
Key exclusion criteria (10 listed)
- Age<16 years old, still in puberty, or disease duration ≤ 1 year;
- Simple obesity, no obvious glandular tissue was found on breast ultrasound examination;
- Male patients with breast developmental disorders secondary to other diseases;
- Patients with contraindications for general anesthesia surgery such as coagulation dysfunction and severe cardiovascular disease, who cannot tolerate surgery;
- The clinical data is basically incomplete;
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 |
|---|---|---|
| Single-port Robotic-assisted Subcutaneous Gland Resection in malesSingle-port Robotic-assisted Subcutaneous Gland Resection for males in the treatment of gynecomastia. | Procedure or surgery | the single-port robotic-assisted subcutaneous gland resection group |
Primary outcome
Patient's and doctor's satisfaction
Time frame: 2 years
Use the Health Status Survey Questionnaire (SF-36) to assess the general condition of patients.
Patient's psychological status using the Self Rating Anxiety Scale (SAS)
Time frame: 2 years
Use the Self Rating Anxiety Scale (SAS) to assess the psychological status of patients.
Patient's psychological status
Time frame: 2 years
Use the Self Rating Depression Scale (SDS) to assess the psychological status of patients.
Patient's sensory
Time frame: 2 years
Using Semmes Weinstein (S-W) monofilament to detect postoperative sensory recovery in patients.
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 20 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Single-port Robotic-assisted Subcutaneous Gland Resection in males in people with Gynecomastia, run by The First Affiliated Hospital with Nanjing Medical University.
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 12 inclusion and 10 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Qiang Ding, Professor (13951731373, dingqiang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's and doctor's satisfaction (time frame: 2 years). The study lists 4 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 20 Jan 2026.