Clinical trial · Interventional

Patient Activated Controlled Expansion (PACE) Trial

Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

NCT01009008CI-TRIAL-00034273PACEcompletedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Breast Reconstruction	—	UNRESOLVED	—
Mastectomy	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Patient Activated Controlled Expansion Device	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Post-mastectomy
description
Post-mastectomy patients undergoing expander reconstruction
interventionNames
1. Device: Patient Activated Controlled Expansion Device

Primary outcomes (1)

measure
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.
timeFrame
6 months

Secondary outcomes (4)

measure
Safety as evidenced by a low incidence of device-related adverse events.
timeFrame
6 months

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

1. 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)
2. Residual gross tumor at the intended expansion site
3. History of or planned adjuvant radiation therapy
4. Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications.
5. Obesity with BMI of 30 or above
6. Current smoker
7. Psychologically unsuitable patient
8. Patient unable to understand the protocol for tissue expansion
9. Planned flight or assent to altitude exceeding 1000 meters above baseline during the expansion period.

References

Publications (2)

DERIVEDConnell 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 25357043
DERIVEDConnell 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 21921761

Registry

Dates and enrollment

Start: Jun 1, 2009
Primary completion: May 1, 2013
Completion: Jun 1, 2013
First posted: Nov 6, 2009
Last update posted: Aug 10, 2018
Enrollment: 40 (actual)
Lead sponsor: AirXpanders, Inc. INDUSTRY
Keywords: cancer, breast cancer, mastectomy, breast reconstruction, reconstruction, tissue expansion, two-stage breast reconstruction, tissue expander, AeroForm, AirXpander

Data updated 22 days agoSource updated Aug 10, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Australia	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.