Evaluation of Safety and Performance of the Orbix Breast Lift System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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".

Detailed Description

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Conditions

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Breast Ptosis

Keywords

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Breast ptosis, Breast lift

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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 -

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Orbix Medical

Principal Investigators

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Marjoes MP Schuckman, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital

Adi Cohen

Role: STUDY_DIRECTOR

Orbix medical

Locations

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Maastricht Univeristy Hospital

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC 08-1-024

Identifier Type: -

Identifier Source: org_study_id