NCT01146275

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Breast Augmentation

Interventions

Type	Name	Description
RADIATION	Radiologial breast examination	MRI of breast, mammography and ultrasound of breast

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-06-17
• Last updated: 2022-09-28
• Results posted: 2014-01-16

Locations

4 sites across 1 country: Sweden