NCT01009008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

3.9 years

First QC Date

November 5, 2009

Last Update Submit

August 8, 2018

Conditions

Breast CancerMastectomyBreast Reconstruction

Keywords

cancerbreast cancermastectomybreast reconstructionreconstructiontissue expansiontwo-stage breast reconstructiontissue expanderAeroFormAirXpander

Outcome Measures

Primary Outcomes (1)

  • Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure.

    6 months

Secondary Outcomes (4)

  • Safety as evidenced by a low incidence of device-related adverse events.

    6 months

  • Time required to achieve desired expansion results.

    6 months

  • Overall patient treatment satisfaction.

    6 months

  • Overall surgeon treatment satisfaction.

    6 months

Study Arms (1)

Post-mastectomy

EXPERIMENTAL

Post-mastectomy patients undergoing expander reconstruction

Device: Patient Activated Controlled Expansion Device

Interventions

Patient Activated Controlled Expansion DeviceDEVICE

Patient activated controlled expansion for post-mastectomy breast reconstruction

Post-mastectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female between the ages of 18 and 65 years.
  • Planned breast reconstruction surgery post-mastectomy.
  • Able to provide informed consent.
  • Able to understand protocol components.

You may not qualify if:

  • Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e., infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration)
  • Residual gross tumor at the intended expansion site
  • History of or planned adjuvant radiation therapy
  • Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications.
  • Obesity with BMI of 30 or above
  • Current smoker
  • Psychologically unsuitable patient
  • Patient unable to understand the protocol for tissue expansion
  • Planned flight or assent to altitude exceeding 1000 meters above baseline during the expansion period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mount Hospital

Perth, Western Australia, 6000, Australia

Location

Related Publications (2)

  • Connell TF. Patient-activated controlled expansion for breast reconstruction using controlled carbon dioxide inflation: confirmation of a feasibility study. Plast Reconstr Surg. 2014 Oct;134(4):503e-511e. doi: 10.1097/PRS.0000000000000551.

    PMID: 25357043DERIVED

  • Connell AF. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg. 2011 Oct;128(4):848-852. doi: 10.1097/PRS.0b013e3182268b80.

    PMID: 21921761DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anthony Connell, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

AU(1)