Patient Activated Controlled Expansion (PACE) Trial

NCT ID: NCT01009008

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-06-30

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.

Detailed Description

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

Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.

Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.

Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.

Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.

Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon.

Each patient will be followed through removal of the tissue expander.

Study Population:

The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.

Conditions

Breast Cancer; Mastectomy; Breast Reconstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Post-mastectomy

Post-mastectomy patients undergoing expander reconstruction

Group Type: EXPERIMENTAL

Patient Activated Controlled Expansion Device

Intervention Type: DEVICE

Patient activated controlled expansion for post-mastectomy breast reconstruction

Interventions

Patient Activated Controlled Expansion Device

Patient activated controlled expansion for post-mastectomy breast reconstruction

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AirXpanders, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Connell, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

The Mount Hospital

Perth, Western Australia, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 25357043 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21921761 (View on PubMed)

Other Identifiers

CTP-0001

Identifier Type: -

Identifier Source: org_study_id