Trials / Completed
CompletedNCT04261608
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 225 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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).
Conditions
Timeline
- Start date
- 2020-04-02
- Primary completion
- 2020-07-04
- Completion
- 2020-07-04
- First posted
- 2020-02-10
- Last updated
- 2020-09-21
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04261608. Inclusion in this directory is not an endorsement.