Females Recently Treated With Macrolane VRF in the BreastsNCT01223066
Macrolane Prospective Survey
An observational study of Females Recently Treated With Macrolane VRF in the Breasts, run by Galderma R&D at 1 site in Sweden.
Trial summary
The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Females Recently Treated With Macrolane VRF in the Breasts
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participating clinics will ask women who have been treated with Macrolane in the breasts in clinical practice, to participate in this survey.
Who may be able to join
- Females recently treated with Macrolane Volume Restoration Factor in the breasts.
- Signed informed consent
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.
The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.
- Keywords
- Macrolane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women treated with Macrolane in the breasts | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: no patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Females Recently Treated With Macrolane VRF in the BreastsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharma Consulting Group AB
- Responsible party
- Sponsor
- Investigators
- Per Hedén, Md PhD, Principal investigator, Akademikliniken Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223066
- Sponsor's protocol ID
- 31GB0906
- Status last verified
- Nov 2012
- First submitted
- 15 Oct 2010
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.
- ClinicalTrials.gov ID
- NCT01223066
- Acronym / sponsor ID
- 31GB0906
- Keywords
- Macrolane
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Collaborators
- Pharma Consulting Group AB
- Study start
- Sep 2010 (actual)
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women treated with Macrolane in the breasts | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participating clinics will ask women who have been treated with Macrolane in the breasts in clinical practice, to participate in this survey.
Key inclusion criteria (2 listed)
- Females recently treated with Macrolane Volume Restoration Factor in the breasts.
- Signed informed consent
Key exclusion criteria (1 listed)
- There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse events
Time frame: up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Females Recently Treated With Macrolane VRF in the Breasts, run by Galderma R&D at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adverse events (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2022.