SEBBIN INTEGRITY Round Implants | NCT05642390

Studies
SEBBIN INTEGRITY Round Implants

NCT05642390

Sponsor

Groupe SEBBIN

Status

Terminated

Last Update Posted

Nov 1, 2024Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Complication
Prosthesis Durability

Interventions

Breast implant

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sponsor's strategic decision

Expanded Access Info

Start Date

Mar 11, 2022Actual

Primary Completion Date

Apr 25, 2024Actual

Completion Date

Apr 25, 2024Actual

First Submitted Date

Nov 30, 2022

First Submission Date that Met QC Criteria

Nov 30, 2022

First Posted Date

Dec 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2024

Last Update Posted Date

Nov 1, 2024Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Name	Type	Description	Arm Group Labels	Other Names
Breast implant	Device	Patients operated for breast augmentation or reconstruction.

Measure	Description	Time Frame
Complication rate		At 10 years of follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Based on self-representation of gender identity

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies