SEBBIN Silicone Gel-filled Testicular Implants

NCT04968470 | Recruiting

• 1 other identifier: PEC 19-05-001
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Complication; Prosthesis Durability

Outcome Measures

Primary Outcomes (1)

• Complication rate

  At 10 years of follow-up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The intended target population for the silicone gel-filled testicular implants of Groupe SEBBIN is any patient (children or adults) with agenesis or testicular atrophy, undescended testicle, testicular tumour, epididymitis / orchitis, or a trauma, for whom an orchidectomy with placement of a testicular prosthesis is indicated. Testicular implants are also indicated for sex reassignment surgeries.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe SEBBIN: lead

Study Sites (2)

UZ Gent

Ghent, 9000, Belgium

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 20, 2021
• Study Start: March 16, 2021
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2035
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

BE (1); FR (1)