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Tissue Expansion in Breast Reconstruction Without Drains

NCT03784859 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2020-10-06

No results posted yet for this study

Summary

The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough confidence in this technique that a larger study can be performed to demonstrate fewer complications (infection, drain-related pain and re-operation rates) when compared to the use of conventional tissue expanders and/or implants with prolonged drain placement.

Conditions

  • Breast Cancer
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Breast Implant; Complications

Interventions

DEVICE

Insertion of Tissue Expander with Fluid Reservoir

Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.

Sponsors & Collaborators

  • Tiger Biosciences, LLC.

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Edward C Ray, MD · Cedars-Sinai Medical Center

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2020-07-13
Completion
2020-10-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03784859 on ClinicalTrials.gov