Evaluation of Safety and Performance of the Orbix Breast... | NCT00774059

Studies
Evaluation of Safety and Performance of the Orbix Breast Lift System

NCT00774059

Sponsor

Maastricht University Medical Center

Status

Withdrawn

Last Update Posted

Oct 12, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Ptosis

Interventions

Breast lift system

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No EC approval obtained

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 15, 2008

First Submission Date that Met QC Criteria

Oct 15, 2008

First Posted Date

Oct 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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".

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast lift system	Device	During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast

Measure	Description	Time Frame
Result after using the breast lift system,recurrence of ptosis.		one year

Measure	Description	Time Frame
complications		one year

Eligibility Module

Eligibility Criteria

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 \

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marjoes MP Schuckman, MD	Maastricht University Hospital	Principal Investigator
Adi Cohen	Orbix medical	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht Univeristy Hospital		Maastricht		6020AZ	Netherlands