Clinical trial · Observational
Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
NCT05097820CI-TRIAL-00080552recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gender Dysphoria | — | UNRESOLVED | — |
| Orchitis | — | UNRESOLVED | — |
| Prosthesis Durability | — | UNRESOLVED | — |
| Testicular Agenesis | — | UNRESOLVED | — |
| Testicular Atrophy | — | UNRESOLVED | — |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
| Testicular Torsion | — | UNRESOLVED | — |
| Undescended Testes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placement of testicular prosthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cisgender patients
- description
- All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons.
- interventionNames
- Device: Placement of testicular prosthesis
- label
- Transgender patients
- description
- All transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery.
- interventionNames
- Device: Placement of testicular prosthesis
Primary outcomes (2)
- measure
- Short term complication rate
- timeFrame
- Within 90 days postoperatively
- description
- Cathegorized according to Clavien-Dindo Classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is an adult or a child at the time of testicular implant placement. * The patient is a candidate to unilateral or bilateral testicular implant placement. * The patient has been informed of the study, has read the patient information letter and provided oral and written consent. * If the patient is of French nationality, he/she must be affiliated to the French Social Security. Exclusion Criteria: * The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis). * The patient was diagnosed with one of the following pathologies: Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease. Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease. Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease. The patient has any other underlying condition that could delay healing. \- Custom-designed implants are used for surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.