MedTrace Logo

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

NCT04261608 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2020-09-21

No results posted yet for this study

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

  • Breast Augmentation
  • Breast Reconstruction

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Jie Luan, Professor · Chinese Academy of Medical Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-02
Primary Completion
2020-07-04
Completion
2020-07-04

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04261608 on ClinicalTrials.gov