A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106

Galderma

Status: Completed

Conditions: Breast Augmentation

Treatments: Radiation: Radiologial breast examination

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146275

31GB0904

Details and patient eligibility

About

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).

Full description

All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments.

The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast.

Enrollment: 6 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant in 31GB0601

Exclusion criteria

• There are no exclusion citeria in this study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Participants in the Pilot study 31GB0601

Other group

Description:

This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiological breast examinations - MRI of breast, mammography and ultrasound of breast

Treatment:

Radiation: Radiologial breast examination