SEBBIN Silicone Gel-filled Testicular Implants

Sebbin

Status: Enrolling

Conditions: Prosthesis Durability; Complication

Study type: Observational

Funder types: Industry

Identifiers

NCT04968470

PEC 19-05-001

Details and patient eligibility

About

This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is an adult or a child at the time of implant placement with SEBBIN implant.
• The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.
• The patient has been informed of the study, has read the patient information letter and -provided oral consent.

Exclusion criteria

• The patient has silicone implants somewhere else than in the scrotal sac.

• 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 a pathology that could delay healing.

• Custom-designed implants are used for surgery.