Breast PtosisNCT00774059
Evaluation of Safety and Performance of the Orbix Breast Lift System
A study testing Breast lift system in people with Breast Ptosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The study is using a new breast lift system to complement a breast-lift operation. In general there will be recurrence of breast-ptosis after a correcting operation. With this device we want to minimize this recurrence and provide an "internal bra". Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Ptosis
- What is being tested?
- Breast lift system
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons:
- Breast ptosis grade I or II (minimal invasive)
- Breast ptosis grade I to IV (open procedure)
- pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. Minimal invasive: breast cup size <C
Who cannot join
- Pregnant or lactating women
- history of surgical procedures involving the ribs and rib cage
- Osteoporosis
- breast implants
- breast carcinoma
- auto-immune disease -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System
The study is using a new breast lift system to complement a breast-lift operation.
In general there will be recurrence of breast-ptosis after a correcting operation.
With this device we want to minimize this recurrence and provide an "internal bra".
- Conditions
- Breast Ptosis
- Being tested
- Breast lift system
- Keywords
- Breast ptosis, Breast lift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast lift systemDevice
During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast
What is being measured
The primary outcome is the main question the study is designed to answer.
Result after using the breast lift system,recurrence of ptosis.
Measured: one year
Secondary outcomes (1)
complications
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
Why it stopped: No EC approval obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PtosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Marjoes MP Schuckman, MD, Principal investigator, Maastricht University HospitalAdi Cohen, Study director, Orbix medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774059
- Sponsor's protocol ID
- MEC 08-1-024
- Status last verified
- Oct 2017
- First submitted
- 15 Oct 2008
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System
- ClinicalTrials.gov ID
- NCT00774059
- Acronym / sponsor ID
- MEC 08-1-024
- Conditions
- Breast Ptosis
- Keywords
- Breast ptosis, Breast lift
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No EC approval obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- First posted
- 16 Oct 2008 (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 is using a new breast lift system to complement a breast-lift operation.
In general there will be recurrence of breast-ptosis after a correcting operation.
With this device we want to minimize this recurrence and provide an "internal bra".
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1.Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons:
- Breast ptosis grade I or II (minimal invasive)
- Breast ptosis grade I to IV (open procedure)
- pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. Minimal invasive: breast cup size <C
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- history of surgical procedures involving the ribs and rib cage
- Osteoporosis
- breast implants
- breast carcinoma
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 |
|---|---|---|
| Breast lift systemDuring a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast | Device | – |
Primary outcome
Result after using the breast lift system,recurrence of ptosis.
Time frame: one year
1 secondary outcome
complications
Time frame: one year
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 12 Oct 2017.
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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.
Marjoes MP Schuckman, MD principal investigator
Maastricht University Hospital
Adi Cohen study director
Orbix medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast lift system in people with Breast Ptosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 6 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 12 Oct 2017. 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 Netherlands. 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?
Result after using the breast lift system,recurrence of ptosis. (time frame: one year). 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 12 Oct 2017.