Breast AugmentationNCT01146275

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

A study testing Radiologial breast examination in people with Breast Augmentation, run by Galderma R&D at 4 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Breast Augmentation
What is being tested?: Radiologial breast examination
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 4 sitesSweden
Study dates: Mar 2010to Aug 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participant in 31GB0601

Who cannot join

There are no exclusion citeria in this study

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

Akademikliniken Öresund
Malmö, 21753
Sophiahemmet
Stockholm, 11486
Akademikliniken
Stockholm, 11542
ProForma Clinic
Stockholm, 118 63

Other trials in Sweden

About this study

Read the 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
Being tested: Radiologial breast examination
Keywords: Patients who participated in pilot study (31GB0601) and performed breast augmentation with previous formulation of Macrolane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiologial breast examinationRadiation
MRI of breast, mammography and ultrasound of breast

Study groups in NCT01146275
Study group	Role	What they receive
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 Receives: Radiation: Radiologial breast examination

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 7 years +/- 6 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Aug 2010

First posted17 Jun 2010 (estimated)
Study startMar 2010
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast AugmentationStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01146275
Sponsor's protocol ID: 31GB0904
Status last verified: Nov 2013
First submitted: 16 Jun 2010
Last updated: 28 Sep 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
ClinicalTrials.gov ID: NCT01146275
Acronym / sponsor ID: 31GB0904
Conditions: Breast Augmentation
Keywords: Patients who participated in pilot study (31GB0601) and performed breast augmentation with previous formulation of Macrolane
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 17 Jun 2010 (estimated)
Results: Posted 16 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Participants in the Pilot study 31GB0601	Other	Radiation: Radiologial breast examinationThis 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

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Participant in 31GB0601

Key exclusion criteria (1 listed)

There are no exclusion citeria in this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiologial breast examinationMRI of breast, mammography and ultrasound of breast	Radiation	Participants in the Pilot study 31GB0601

Primary outcome

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.
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

Results and safety

Results posted to the registry on 16 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants in the Pilot Study 31GB0601	6	6

Primary outcome: 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. Number. Unit: participants with remaining product

Measure	Participants in the Pilot Study 31GB0601 n = 4
Value	4

Population analysed: MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI.

Primary outcome: To Evaluate the Long Term Safety of Macrolane in Breast Enhancement

Time frame: 7 years +/- 6 months post treatment. Number. Unit: participants

Measure	Participants in the Pilot Study 31GB0601 n = 6
Value	0

Population analysed: Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants in the Pilot Study 31GB0601	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Augmentation

RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
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Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Per Hedén, MD, PhD principal investigator

Akademikliniken, Stockholm

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Radiologial breast examination in people with Breast Augmentation, run by Galderma R&D at 4 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.