SEBBIN Silicone Gel-filled Testicular Implants

March 5, 2024 updated by: Groupe SEBBIN

Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
          • Anne-Françoise Spinoit, MD
          • Phone Number: +32 9 332 21 11
          • Email: info@uzgent.be
        • Principal Investigator:
          • Anne-Françoise Spinoit, MD
  • France
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
        • Principal Investigator:
          • Nicolas Morel Journel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complication rate
Time Frame: At 10 years of follow-up
At 10 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe SEBBIN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2034

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEC 19-05-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe