SEBBIN Silicone Gel-filled Testicular Implants

Complication Clinical Trial

Official title:

Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968470
• Other study ID #: PEC 19-05-001
• Status: Recruiting
• Start date: March 16, 2021
• Est. completion date: September 2034

Study information

• Verified date: March 2024
• Source: Groupe SEBBIN
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2034
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Prosthesis Durability
• Prosthesis Failure

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Groupe SEBBIN

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate		At 10 years of follow-up