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Patient Activated Controlled Expansion (PACE) Trial

NCT01009008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-08-10

No results posted yet for this study

Summary

The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.

Conditions

Interventions

DEVICE

Patient Activated Controlled Expansion Device

Patient activated controlled expansion for post-mastectomy breast reconstruction

Sponsors & Collaborators

  • AirXpanders, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony Connell, M.D.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Australia

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 NCT01009008 on ClinicalTrials.gov