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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01146275
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : January 16, 2014
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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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).

Condition or disease Intervention/treatment Phase
Breast Augmentation Radiation: Radiologial breast examination Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
Study Start Date : March 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010
Arms and Interventions
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Arm Intervention/treatment
Participants in the Pilot study 31GB0601

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
MRI of breast, mammography and ultrasound of breast


Outcome Measures
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Primary Outcome Measures :
  1. To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation [ Time Frame: 7 years +/- 6months post treatment ]
    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.

  2. To Evaluate the Long Term Safety of Macrolane in Breast Enhancement [ Time Frame: 7 years +/- 6 months post treatment ]

    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



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant in 31GB0601

Exclusion Criteria:

  • There are no exclusion citeria in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146275


Locations
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Sweden
Akademikliniken Öresund
Malmö, Sweden, 21753
Sophiahemmet
Stockholm, Sweden, 11486
Akademikliniken
Stockholm, Sweden, 11542
ProForma Clinic
Stockholm, Sweden, 118 63
Sponsors and Collaborators
Q-Med AB
Investigators
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Principal Investigator: Per Hedén, MD, PhD Akademikliniken, Stockholm
More Information
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01146275    
Other Study ID Numbers: 31GB0904
First Posted: June 17, 2010    Key Record Dates
Results First Posted: January 16, 2014
Last Update Posted: January 16, 2014
Last Verified: November 2013
Keywords provided by Q-Med AB:
Patients who participated in pilot study (31GB0601) and performed breast augmentation with previous formulation of Macrolane