Evaluation of Safety and Performance of the Orbix Breast Lift System
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Maastricht University Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Maastricht University Medical Center
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00774059
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 15, 2008 | ||||||||
| Last Updated Date | October 15, 2008 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Result after using the breast lift system,recurrence of ptosis. [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
complications [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Safety and Performance of the Orbix Breast Lift System | ||||||||
| Official Title ICMJE | Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System | ||||||||
| 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". |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Breast Ptosis | ||||||||
| Intervention ICMJE | Device: Breast 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 |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 5 | ||||||||
| Estimated Completion Date | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 30 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00774059 | ||||||||
| Other Study ID Numbers ICMJE | MEC 08-1-024 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Adi Cohen, Orbix Medical | ||||||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||||||
| Verification Date | October 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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