Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05097820
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2021-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D013086', 'term': 'Spermatic Cord Torsion'}, {'id': 'D000068116', 'term': 'Gender Dysphoria'}, {'id': 'D003456', 'term': 'Cryptorchidism'}, {'id': 'D009920', 'term': 'Orchitis'}, {'id': 'C537770', 'term': 'Anorchia'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short term complication rate', 'timeFrame': 'Within 90 days postoperatively', 'description': 'Cathegorized according to Clavien-Dindo Classification'}, {'measure': 'Long term complication rate', 'timeFrame': 'At 2 years of follow-up', 'description': 'Desciption of overall complications related to testicular prosthesis placement.'}], 'secondaryOutcomes': [{'measure': 'Change in self-esteem scoring', 'timeFrame': 'Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up', 'description': 'Assessed by the Rosenberg Self-Esteem Scale (strongly disagree - strongly agree)'}, {'measure': 'Body image of scrotum', 'timeFrame': 'Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up', 'description': 'Assessed with non-validated likert scale quationnaires'}, {'measure': 'Satisfaction with prosthesis', 'timeFrame': 'Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up', 'description': 'Assessed with non-validated likert scale quationnaires'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['testicular prosthesis'], 'conditions': ['Testicular Cancer', 'Testicular Torsion', 'Gender Dysphoria', 'Undescended Testes', 'Orchitis', 'Testicular Agenesis', 'Testicular Atrophy', 'Prosthesis Durability']}, 'descriptionModule': {'briefSummary': 'To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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.\n\nThe medical grade raw materials used for the manufacturing of these prostheses are bio-compatible and completely traceable. The substances belong to the polydimethylsiloxane family.\n\nThis 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any undividual with an underlying reason for testicular loss with a specific wish for testicular implant placement.\n\nAny patient with the underlying condidion of gender dysphoria with the specific wish for testicular implant placement as a form of gender reassignment surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is an adult or a child at the time of testicular implant placement.\n* The patient is a candidate to unilateral or bilateral testicular implant placement.\n* The patient has been informed of the study, has read the patient information letter and provided oral and written consent.\n* If the patient is of French nationality, he/she must be affiliated to the French Social Security.\n\nExclusion Criteria:\n\n* The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).\n* The patient was diagnosed with one of the following pathologies:\n\nSystemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.\n\nRheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.\n\nArthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.\n\nThe patient has any other underlying condition that could delay healing.\n\n\\- Custom-designed implants are used for surgery.'}, 'identificationModule': {'nctId': 'NCT05097820', 'briefTitle': 'Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants', 'orgStudyIdInfo': {'id': 'BC-8299'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cisgender patients', 'description': 'All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons.', 'interventionNames': ['Device: Placement of testicular prosthesis']}, {'label': 'Transgender patients', 'description': 'All transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery.', 'interventionNames': ['Device: Placement of testicular prosthesis']}], 'interventions': [{'name': 'Placement of testicular prosthesis', 'type': 'DEVICE', 'description': 'The surgical implantation of one or two testicular prostheses on request of the patient', 'armGroupLabels': ['Cisgender patients', 'Transgender patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anne-Françoise Spinoit, MD, PhD', 'role': 'CONTACT', 'email': 'anne-francoise.spinoit@uzgent.be', 'phone': '003293322276'}, {'name': 'Wietse Claeys, MD, PhD', 'role': 'CONTACT', 'email': 'wietse.claeys@uzgent.be', 'phone': '003293321702'}, {'name': 'Anne-Françoise Spinoit, MD, PhD', 'role': 'CONTACT'}, {'name': 'Wietse Claeys, MD', 'role': 'CONTACT'}, {'name': 'Celine Sinatti, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Anne-Françoise Spinoit, MD, PhD', 'role': 'CONTACT', 'email': 'anne-francoise.spinoit@uzgent.be', 'phone': '003293322276'}, {'name': 'Wietse Claeys, MD', 'role': 'CONTACT', 'email': 'wietse.claeys@uzgent.be', 'phone': '003293322276'}], 'overallOfficials': [{'name': 'Anne-Françoise Spinoit, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After publication of findings, the individual patient data can be provided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Groupe SEBBIN', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}