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NCT03744273
Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
NA trial testing breast capsule biopsy in Breast Neoplasms. Completed in 26 May 2015.
26 May 2015
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Start date | 3 November 2013 |
| Primary completion | 26 May 2015 |
| Estimated completion | 26 May 2015 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- breast capsule biopsy
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Mammaplasty — all drugs for Mammaplasty →
- Acellular Dermis — all drugs for Acellular Dermis →
Sponsor
Samsung Medical Center
Who can join
Adults 20 to 70, female only, with Breast Neoplasms or Mammaplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions. This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.
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 NCT03744273
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03744273 (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 Samsung Medical Center
- Last refreshed: 19 November 2018
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/NCT03744273.
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