SEBBIN INTEGRITY Round Implants

NCT05642390 | Terminated

• 1 other identifier: PEC 20-08-001
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY 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.

Conditions

Complication; Prosthesis Durability

Outcome Measures

Primary Outcomes (1)

• Complication rate

  At 10 years of follow-up

Interventions

Breast implant DEVICE

Patients operated for breast augmentation or reconstruction.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from prospective adult patients operated for breast augmentation or reconstruction, unilaterally or bilaterally with SEBBIN silicone gel filled INTEGRITY mammary implants.

You may qualify if:

• The patient is at least 18-year-old.
• The patient is a woman.
• The patient was prescribed with a surgery for a breast augmentation or reconstruction, unilaterally or bilaterally with silicone gel-filled SEBBIN INTEGRITY mammary implants.
• The patient has been informed of the study, has read the patient information letter and provided consent in writing.

You may not qualify if:

• The patient is pregnant or breastfeeding.
• The patient has silicone implants somewhere else than in the breast.
• 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.
• History of implant-associated anaplastic large cell lymphoma (BIA-ALCL).
• Symptomatic autoimmune disease.
• The patient has a pathology that could delay healing (does not apply to the reconstruction group).
• The patient has cancer (does not apply to the reconstruction group).
• The patient has anatomical or physiological conditions that could lead to postoperative complications.

Sponsors & Collaborators

• Groupe SEBBIN: lead

Study Sites (1)

SEBBIN

Saint-Ouen-l'Aumône, France

Location

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Breast Implants

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: March 11, 2022
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

FR (1)