Testicular CancerNCT05097820
Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
An observational study of Testicular Cancer and Testicular Torsion, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants. Read more about this study
- Who is it for?
- Ages 0 to 110 years
- Conditions the study is for
- Testicular Cancer, Testicular Torsion, Gender Dysphoria
- What is being tested?
- Placement of testicular prosthesis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Feb 2021to 31 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any undividual with an underlying reason for testicular loss with a specific wish for testicular implant placement. Any patient with the underlying condidion of gender dysphoria with the specific wish for testicular implant placement as a form of gender reassignment surgery.
Who may be able to join
- 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.
Who cannot join
- The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, East-Flanders, 9000
Anne-Françoise Spinoit, MD, PhD, 003293322276, anne-francoise.spinoit@uzgent.be
Wietse Claeys, MD, PhD, 003293321702, wietse.claeys@uzgent.be
About this study
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
Read the detailed description
Testicular implants made from various materials have been in use since 1941. The lack of a testicle has proven to be a psychologically traumatic experience for men of all ages. Therefore, testicular implants are placed in the scrotum for various reasons on request of the patient.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.
The main complications after testicular implant placement recorded in the literature include extrusion, scrotal contraction, pain, hematoma, and infection. The literature about testicular implant is sparse, and no report on the use of SEBBIN silicone gel-filled testicular implants have been identified in the scientific literature.
The Gel-filled Testicular Implant medical devices are manufactured by GROUPE SEBBIN under the brand name 'Laboratoires SEBBIN'. The Gel-filled Testicular Implant medical devices are presented sterile (Ethylene oxide sterilization) and are double wrapped for single use.
The medical grade raw materials used for the manufacturing of these prostheses are bio-compatible and completely traceable. The substances belong to the polydimethylsiloxane family.
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 data on the safety and effectiveness of the device. For this purpose, the overall short and long term complication rate and complication grade. Secondly, the investigators evaluate patient satisfaction and quality of life by use of questionnaires
- Conditions
- Testicular Cancer, Testicular Torsion, Gender Dysphoria, Undescended Testes, Orchitis, Testicular Agenesis
- Being tested
- Placement of testicular prosthesis
- Keywords
- testicular prosthesis
- Medical subject headings
- Testicular Neoplasms, Spermatic Cord Torsion, Gender Dysphoria, Cryptorchidism, Orchitis, Anorchia, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of testicular prosthesisDevice
The surgical implantation of one or two testicular prostheses on request of the patient
| Study group | Role | What they receive |
|---|---|---|
| Cisgender patients | All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons. Receives: Device: Placement of testicular prosthesis | |
| Transgender patients | All transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery. Receives: Device: Placement of testicular prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term complication rate
Cathegorized according to Clavien-Dindo Classification
Measured: Within 90 days postoperatively
Long term complication rate
Desciption of overall complications related to testicular prosthesis placement.
Measured: At 2 years of follow-up
Secondary outcomes (3)
Change in self-esteem scoring
Assessed by the Rosenberg Self-Esteem Scale (strongly disagree - strongly agree)
Measured: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Body image of scrotum
Assessed with non-validated likert scale quationnaires
Measured: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Satisfaction with prosthesis
Assessed with non-validated likert scale quationnaires
Measured: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start5 Feb 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe SEBBIN
- Responsible party
- Sponsor
- Investigators
- Anne-Françoise Spinoit, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097820
- Sponsor's protocol ID
- BC-8299
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publication of findings, the individual patient data can be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
- ClinicalTrials.gov ID
- NCT05097820
- Acronym / sponsor ID
- BC-8299
- Conditions
- Testicular Cancer, Testicular Torsion, Gender Dysphoria, Undescended Testes, Orchitis, Testicular Agenesis
- Keywords
- testicular prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Groupe SEBBIN
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
Detailed description
Testicular implants made from various materials have been in use since 1941. The lack of a testicle has proven to be a psychologically traumatic experience for men of all ages. Therefore, testicular implants are placed in the scrotum for various reasons on request of the patient.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.
The main complications after testicular implant placement recorded in the literature include extrusion, scrotal contraction, pain, hematoma, and infection. The literature about testicular implant is sparse, and no report on the use of SEBBIN silicone gel-filled testicular implants have been identified in the scientific literature.
The Gel-filled Testicular Implant medical devices are manufactured by GROUPE SEBBIN under the brand name 'Laboratoires SEBBIN'. The Gel-filled Testicular Implant medical devices are presented sterile (Ethylene oxide sterilization) and are double wrapped for single use.
The medical grade raw materials used for the manufacturing of these prostheses are bio-compatible and completely traceable. The substances belong to the polydimethylsiloxane family.
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 data on the safety and effectiveness of the device. For this purpose, the overall short and long term complication rate and complication grade. Secondly, the investigators evaluate patient satisfaction and quality of life by use of questionnaires
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisgender patients | – | Device: Placement of testicular prosthesisAll cisgender patients in which one or two testicular prostheses are to be implanted for various reasons. |
| Transgender patients | – | Device: Placement of testicular prosthesisAll transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery. |
Who may qualify
- Ages
- 0 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any undividual with an underlying reason for testicular loss with a specific wish for testicular implant placement. Any patient with the underlying condidion of gender dysphoria with the specific wish for testicular implant placement as a form of gender reassignment surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of testicular prosthesisThe surgical implantation of one or two testicular prostheses on request of the patient | Device | Cisgender patients, Transgender patients |
Primary outcome
Short term complication rate
Time frame: Within 90 days postoperatively
Cathegorized according to Clavien-Dindo Classification
Long term complication rate
Time frame: At 2 years of follow-up
Desciption of overall complications related to testicular prosthesis placement.
3 secondary outcomes
Change in self-esteem scoring
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Body image of scrotum
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Satisfaction with prosthesis
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided. After publication of findings, the individual patient data can be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Françoise Spinoit, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer and Testicular Torsion, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Françoise Spinoit, MD, PhD (003293322276, anne-francoise.spinoit@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term complication rate (time frame: Within 90 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.