At a glance
ClinicalIndex Comparison RecordN/ACompleted· 201 enrolled
Drug / intervention
BIOCELL™ Textured 410 Implantdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)
In Brief
An observational study evaluating BIOCELL™ Textured 410 Implant for Breast Implantation. Completed, enrolled 201 participants across 5 sites in 5 countries.
Detailed Summary
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Implantation
CountriesFrance, Germany, Israel, Spain, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionOct 2014
TodayJul 2026
First PostedMay 7, 2014
Enrollment StartMay 1, 2014
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.2 years ago
Interventions
BIOCELL™ Textured 410 Implantdevice
Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.