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Clinical Trials/NCT04261608
NCT04261608
Completed
Not Applicable

A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China

Allergan6 sites in 1 country225 target enrollmentApril 2, 2020
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ConditionsBreast AugmentationBreast Reconstruction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Augmentation
Sponsor
Allergan
Enrollment
225
Locations
6
Primary Endpoint
Number of participants who experienced adverse events
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019. The safety of McGhan breast implants (textured and smooth) will be evaluated based on occurrence of local complications including capsular contracture, malposition of implant, seroma/late seroma and anaplastic large cell lymphoma (ALCL).

Registry
clinicaltrials.gov
Start Date
April 2, 2020
End Date
July 4, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Allergan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of participants who experienced adverse events

Time Frame: up to 4 years

Study Sites (6)

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