Trial · NCT07904091
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
NCT07904091, Active not recruiting, Laboratoires ARION
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years. Trials, record NCT07904091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904091
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
- NCT number
- NCT07904091
- Status
- Active not recruiting
- Enrollment
- 630 participants, estimated
- Lead sponsor
- Laboratoires ARION
- Conditions
- Breast Augmentation, Breast Reconstruction
- Interventions
- Breast augmentation, Breast reconstruction
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | rate of women who had at least one re-intervention within the 10 years of follow-up. | 10 years of follow-up | rate of subjects who had at least one re-intervention within the 10 years of follow-up |
| Secondary | Evaluation of the reintervention rate by subgroups | 10 years of follow-up | Rate of patients who had at least one re-intervention within the 10 years of follow-up by subgroups |
| Secondary | Evaluation of reintervention rate related to complications | 10 years of follow-up | Rate of patients who had at least one re-intervention related to complications within the 10 years of follow-up |
| Secondary | Evaluation of high clinical interest adverse events | 10 years of follow-up | Rate of patients with at least one adverse event of high clinical interest within the 10 years of follow up: carcinoma, BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma), neurological diseases, connective tissue diseases |
| Secondary | Evaluation of common complications of breast surgery | 10 years of follow-up | Complications rate of Common complications of breast surgery by subgroups (textures and indications) within 10 years: Rupture/fissure/transudation (A0410) ; Capsular contraction (A010102) ; Extrusion (A0411) ; Esthetic issues (asymmetry, rotation, malposition, migration, ptosis, folds) (A0104) |
| Secondary | Evaluation of systemic complications | 10 years of follow-up | Rate of patients who had at least one systemic complication within the 10 years follow-up: * Cardiovascular: damage to blood vessels, thrombosis, pulmonary embolism, Ischemic Heart Disease * Nervous: Nervous System Injury, neurological reactions * Metaplasic: LAGC-AIM, breast cancer * Infectious: Toxic Shock Syndrome * Conjonctive: Connective Tissue Disease * Autoimmune disorder (ASIA syndrome, siliconoma) |
| Secondary | Evaluation of local complication | 10 years of follow-up | Rate of implants with at least one local complication within 10 years of follow-up: * Vascular: hematoma, bleedings * Cutaneous: abnormal healing, erythema, Hyperesthesia * Peri-prosthetic: capsular contracture , calcifications, atrophy in pectoralis muscle * Inflammatory: hypertrophy, oedema, granuloma, seroma, lymphorrhea * Local infection * Necrosis * Pain |
| Secondary | Evaluation of Quality of life | 10 years of follow-up | Evaluation of the Quality of life by a 3-point scale (Likert scale) |
| Secondary | Evaluation of Self-esteem | 10 years of follow-up | Evaluation of the Self-esteem by Rosenberg' scale |
| Secondary | Evaluation of patient satisfaction | 10 years of follow-up | Rate of satisfied patient at 10 years post-implantation according to a 5-point scale (Likert scale) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07904091
GET https://conductscience.org/api/trials/v1/NCT07904091/registered