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RecruitingNCT04968470Updated Oct 31, 2024

SEBBIN Silicone Gel-filled Testicular Implants

An observational study in Complication and Prosthesis Durability, sponsored by Groupe SEBBIN. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Groupe SEBBIN · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Sex
All
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Study 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.

02

Conditions studied

  • Complication
  • Prosthesis Durability

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03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 100 is below the median of 119 across 49 observational studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Groupe SEBBIN is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Complication rate

    Time frame: At 10 years of follow-up

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Study locations

2 of 2 sites recruiting
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2021 (actual). Primary completion is estimated for Sep 2025, 54 months after the start.

Of 28 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 184. This study's planned 54 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2021
First posted
Jul 20, 2021
StartActual
Mar 16, 2021
Primary completionEst.
Sep 2025
CompletionEst.
Sep 2035
Last update
Oct 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04968470
Lead sponsor
Groupe SEBBIN
Responsible party
Sponsor
First posted
Jul 20, 2021
Start date
Mar 16, 2021
Primary completion
Sep 2025 (estimated)
Completion
Sep 2035 (estimated)
Last update
Oct 31, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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