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NCT05097820Recruiting

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
21 Sept 2021
Start date
5 Feb 2021
Primary completion date
31 Dec 2030
Lead sponsor
University Hospital, Ghent
NCT number
NCT05097820

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 5 Feb 2021 to the primary completion date, 31 Dec 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).

Other illness

  • 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 any other underlying condition that could delay healing.
    • \- Custom-designed implants are used for surgery.

Who the study is looking for

  • The patient is an adult or a child at the time of testicular implant placement.
  • The patient is a candidate to unilateral or bilateral testicular implant placement.
  • The patient has been informed of the study, has read the patient information letter and provided oral and written consent.
  • If the patient is of French nationality, he/she must be affiliated to the French Social Security.

Age in the registry: 0 years to 110 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Ghent
Coordinator of this site? Confirm its status		GhentBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.