To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resec… (NCT07353411) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males
20 participantsStarted 2026-01-01
Plain-language 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. 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.
Who can participate
Age range
17 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient's and doctor's satisfaction
Timeframe: 2 years
2
Patient's psychological status using the Self Rating Anxiety Scale (SAS)
Timeframe: 2 years
3
Patient's psychological status
Timeframe: 2 years
4
Patient's sensory
Timeframe: 2 years
Trial details
NCT IDNCT07353411
SponsorThe First Affiliated Hospital with Nanjing Medical University
. No other serious underlying diseases in the past;
Exclusion criteria
. 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;
. 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;