N/A
N=6
A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
Breast Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT01146275 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation — 4 participants with remaining product
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiologial breast examination (Radiation)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Galderma R&D
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation |
4 | — |
| PRIMARY To Evaluate the Long Term Safety of Macrolane in Breast Enhancement |
— | — |
Summary
Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).
Eligibility Criteria
Inclusion Criteria
- Participant in 31GB0601
Exclusion Criteria
- There are no exclusion citeria in this study
Data sourced from ClinicalTrials.gov (NCT01146275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.