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NCT04261608
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
trial in Breast Augmentation in 225 participants. Completed in 4 July 2020.
4 July 2020
Quick facts
| Lead sponsor | Allergan |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 225 |
| Start date | 2 April 2020 |
| Primary completion | 4 July 2020 |
| Estimated completion | 4 July 2020 |
| Sites | 6 locations across China |
Conditions studied
- Breast Augmentation — all drugs for Breast Augmentation →
- Breast Reconstruction — all drugs for Breast Reconstruction →
Sponsor
Allergan — full company profile →
Who can join
18 and older, any sex, with Breast Augmentation or Breast Reconstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04261608
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Allergan trials
Trials by the same sponsor.
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- NCT05152576 — A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants Wi · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04261608 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Allergan
- Last refreshed: 21 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04261608.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing