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

NCT01146275 | Completed Results

• 1 other identifier: 31GB0904
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Breast Augmentation

Keywords

Patients who participated in pilot study (31GB0601) and performed breast augmentation with previous formulation of Macrolane

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Participants in the Pilot study 31GB0601

OTHER

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

Radiation: Radiologial breast examination

Interventions

Radiologial breast examination RADIATION

MRI of breast, mammography and ultrasound of breast

Participants in the Pilot study 31GB0601

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant in 31GB0601

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (4)

Akademikliniken Öresund

Malmo, 21753, Sweden

Location

Sophiahemmet

Stockholm, 11486, Sweden

Location

Akademikliniken

Stockholm, 11542, Sweden

Location

ProForma Clinic

Stockholm, 118 63, Sweden

Location

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Q-Med AB

reception.SEUPP@galderma.com

+46 (0) 18 4749000

Study Officials

• Per Hedén, MD, PhD

  Akademikliniken, Stockholm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 28, 2022
• Results First Posted: January 16, 2014

Record last verified: 2013-11

Locations

SE (4)