SEBBIN Silicone Gel-filled Testicular Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2035-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Complication Prosthesis Durability

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No