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NCT01146275 Clinical Trial

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

Breast Augmentation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01146275
Other study ID # 31GB0904
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date August 2010

Study information
Verified date November 2013
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Participant in 31GB0601 Exclusion Criteria: - There are no exclusion citeria in this study

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Radiologial breast examination
MRI of breast, mammography and ultrasound of breast

Locations
Country Name City State
Sweden Akademikliniken Öresund Malmö
Sweden Akademikliniken Stockholm
Sweden ProForma Clinic Stockholm
Sweden Sophiahemmet Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment. 7 years +/- 6months post treatment
Primary To Evaluate the Long Term Safety of Macrolane in Breast Enhancement To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation.
Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation		 7 years +/- 6 months post treatment
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