An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01609400

Enrollment

Registered

2012-06-01

Start date

2011-12-31

Completion date

2013-08-31

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Enhancement

Brief summary

The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 50 Years

Healthy volunteers

Inclusion criteria

* subject treated with NASHA-gel in the breasts in study 31GB0607 * signed informed consent

Exclusion criteria

* no

Design outcomes

Primary

Measure	Time frame
Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI	4 years
Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI	6 years

Secondary

Measure	Time frame
Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.	4 years
Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos	4 years
Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)	4 years

Outcome results