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Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study

NCT03744273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-11-19

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasms
  • Mammaplasty
  • Acellular Dermis

Interventions

PROCEDURE

breast capsule biopsy

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Jai-Kyong Pyon, MD,PhD · Samsung Medical Center

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-03
Primary Completion
2015-05-26
Completion
2015-05-26

Countries

  • South Korea

Study Locations

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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 NCT03744273 on ClinicalTrials.gov