Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

NCT05097820 | Recruiting

• 1 other identifier: BC-8299
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Testicular Cancer; Testicular Torsion; Gender Dysphoria; Undescended Testes; Orchitis; Testicular Agenesis; Testicular Atrophy; Prosthesis Durability

Keywords

testicular prosthesis

Outcome Measures

Primary Outcomes (2)

• Short term complication rate

  Cathegorized according to Clavien-Dindo Classification

  Within 90 days postoperatively

• Long term complication rate

  Desciption of overall complications related to testicular prosthesis placement.

  At 2 years of follow-up

Secondary Outcomes (3)

• Change in self-esteem scoring

  Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up

• Body image of scrotum

  Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up

• Satisfaction with prosthesis

  Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up

Study Arms (2)

Cisgender patients

All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons.

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.

Device: Placement of testicular prosthesis

Interventions

Placement of testicular prosthesis DEVICE

The surgical implantation of one or two testicular prostheses on request of the patient

Cisgender patients; Transgender patients

Eligibility Criteria

• Age: 0 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Groupe SEBBIN: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms; Spermatic Cord Torsion; Gender Dysphoria; Cryptorchidism; Orchitis; Anorchia; Prosthesis Failure

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Sexual Dysfunctions, Psychological; Mental Disorders; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne-Françoise Spinoit, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Françoise Spinoit, MD, PhD

CONTACT

003293322276; anne-francoise.spinoit@uzgent.be

Wietse Claeys, MD

CONTACT

003293322276; wietse.claeys@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 28, 2021
• Study Start: February 5, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)