A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT04261608
Collaborator
(none)
225
6
3.1
37.5
12.3
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
225 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
Actual Study Start Date
:
Apr 2, 2020
Actual Primary Completion Date
:
Jul 4, 2020
Actual Study Completion Date
:
Jul 4, 2020
Outcome Measures
Primary Outcome Measures
- Number of participants who experienced adverse events [up to 4 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Lidu Plastic Surgery Hospital | Beijing | Beijing | China | |
| 2 | Plastic Surgery Hospital Chinese Academy of Medical Sciences | Beijing | Beijing | China | |
| 3 | Guangzhou Sogood Medical Cosmetology Hospital | Guangzhou | Guangdong | China | |
| 4 | The Second People's Hospital of Guangdong Province | Guangzhou | Guangdong | China | |
| 5 | Changsha Yan Han Medical Plastic Hospital | Changsha | Hunan | China | |
| 6 | Hunan Yamei Medical Cosmetology Hospital | Changsha | Hunan | China |
Sponsors and Collaborators
- Allergan
Investigators
- Principal Investigator: Jie Luan, Professor, Chinese Academy of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Additional information on study locations near you may be found at AllerganClinicalTrials.com.
- To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT04261608
Other Study ID Numbers:
- MED-EPI-PLS-0637
First Posted:
Feb 10, 2020
Last Update Posted:
Sep 21, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No