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NCT04261608 Clinical Trial

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

Breast Reconstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04261608
Other study ID # MED-EPI-PLS-0637
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2, 2020
Est. completion date July 4, 2020

Study information
Verified date September 2020
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date July 4, 2020
Est. primary completion date July 4, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

-

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Beijing Lidu Plastic Surgery Hospital Beijing Beijing
China Plastic Surgery Hospital Chinese Academy of Medical Sciences Beijing Beijing
China Changsha Yan Han Medical Plastic Hospital Changsha Hunan
China Hunan Yamei Medical Cosmetology Hospital Changsha Hunan
China Guangzhou Sogood Medical Cosmetology Hospital Guangzhou Guangdong
China The Second People's Hospital of Guangdong Province Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who experienced adverse events up to 4 years
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