Swedish Macrolane Registry | NCT01145235

Studies
Swedish Macrolane Registry

NCT01145235

Sponsor

Galderma R&D

Status

Completed

Last Update Posted

Aug 25, 2022Actual

Enrollment

1,300Actual

Phase

Not provided

Conditions

Breast Augmentation

Interventions

Not provided

Countries

Sweden

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010Actual

Primary Completion Date

Jan 2019Actual

Completion Date

Jan 2019Actual

First Submitted Date

Jun 15, 2010

First Submission Date that Met QC Criteria

Jun 15, 2010

First Posted Date

Jun 16, 2010Estimated

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

Aug 24, 2022

Last Update Posted Date

Aug 25, 2022Actual

Description Module

Brief Summary

A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Actual

Label	Type	Description	Intervention Names
Females previously treated with Macrolane in their breasts.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To document the incidence of breast cancer in female subjects after treatment with Macrolane VRFs in the breasts when the product is used in clinical practice.		2010-2015

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females previously treated with Macrolane VRF in the breasts
Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment.

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All clinics treating females with Macrolane in the breast will be asked to participate.

Sampling Method

Non-Probability Sample