A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
1 other identifier
observational
225
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedStudy Start
First participant enrolled
April 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2020
CompletedSeptember 21, 2020
September 1, 2020
3 months
February 6, 2020
September 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants who experienced adverse events
up to 4 years
Eligibility Criteria
Retrospective chart review study where data will be collected from all eligible patients who consecutively underwent breast implant surgery with McGhan single lumen gel-filled Breast implants from 24 December 2015 to 31 December 2019.
You may qualify if:
- patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (6)
Beijing Lidu Plastic Surgery Hospital
Beijing, Beijing Municipality, China
Plastic Surgery Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Guangzhou Sogood Medical Cosmetology Hospital
Guangzhou, Guangdong, China
The Second People's Hospital of Guangdong Province
Guangzhou, Guangdong, China
Changsha Yan Han Medical Plastic Hospital
Changsha, Hunan, China
Hunan Yamei Medical Cosmetology Hospital
Changsha, Hunan, China
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Luan, Professor
Chinese Academy of Medical Sciences
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2020
First Posted
February 10, 2020
Study Start
April 2, 2020
Primary Completion
July 4, 2020
Study Completion
July 4, 2020
Last Updated
September 21, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
- Access Criteria
- To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.