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 range17 Years – 75 Years
SexMALE
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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;
✓. Suspected malignant transformation;
✓. 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;
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
✕. 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;