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Evaluation of Safety and Performance of the Orbix Breast Lift System

Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00774059
Enrollment
0
Registered
2008-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Ptosis

Keywords

Breast ptosis, Breast lift

Brief 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.

Interventions

DEVICEBreast lift system

During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

1. Pregnant or lactating women 2. history of surgical procedures involving the ribs and rib cage 3. Osteoporosis 4. breast implants 5. breast carcinoma 6. auto-immune disease -

Design outcomes

Primary

MeasureTime frame
Result after using the breast lift system,recurrence of ptosis.one year

Secondary

MeasureTime frame
complicationsone year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026