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Clinical randomized controlled study on the promotion of hypospadias repair by SVF-gel.

Clinical randomized controlled study on the promotion of hypospadias repair by SVF-gel.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094471
Enrollment
Unknown
Registered
2024-12-23
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Interventions

Experimental group:Inject SVF-gel
Control group:None

Sponsors

Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The age of the patient on the day of signing the informed consent form is more than 6 months; 2. Diagnosis of congenital hypospadias; 3. No surgical treatment; 4. Patients who need to reconstruct the urethra with a leather tube to evaluate the surgical plan; 5. Those whose vital signs are stable and can tolerate surgery after routine examination; 6. Patients who are in good mental state, able to follow the doctor's instructions, and have regular follow-up visits; 7. The patient or legal guardian understands and is willing to participate in this clinical trial and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pre-existing diseases that will affect the healing of the reconstituted urethra (such as malignant tumors, autoimmune diseases); 2. Patients are immunosuppressed during the screening period due to underlying disease, long-term immunosuppressant therapy, or use of high-dose glucocorticoids (i.e., receiving = 40 mg of prednisone or the equivalent of prednisone daily for = 2 weeks); 3. Difficult-to-control hyperglycemia (e.g., HbA1c >12.0%); 4. Those with serious uncontrolled diseases or acute infections in the whole body and other serious organ diseases such as heart, lung and encephalopathy; 5. Patients with mental illness; 6. Those who are considered inappropriate by the researchers; 7. Patient has participated in this study at any time in the past.

Design outcomes

Primary

MeasureTime frame
Incidence of urinary fistula;

Countries

China

Contacts

Public ContactXiaolian Xiao

Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

xxlhsiao@126.com+86 15625091215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026