ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000400167p

Ethics application status

Not yet submitted

Date submitted

2/03/2019

Date registered

12/03/2019

Date last updated

18/06/2021

Date data sharing statement initially provided

12/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Patient-controlled needle-free carbon dioxide insufflated breast expander implant (Aeroform®, AirXpanders®) in breast reconstruction: multi-surgeon prospective case series

Scientific title

Patient-controlled needle-free carbon dioxide insufflated breast expander implant (Aeroform®, AirXpanders®) in breast reconstruction: multi-surgeon prospective case series

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1229-5013

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

breast reconstruction

Condition category

Condition code

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Insertion of patient-controlled needle-free carbon dioxide insufflated breast expander implants (Aeroform®, AirXpanders®)

The expander is inserted during a surgical procedure under general anaesthetic which takes approximately one hour. The incision used is generally the existing incision from the preceding mastectomy. After the surgical procedure, patients are usually discharged 1-2 days postop. There is a clinic visit one week and two weeks postop. If wound healing is satisfactory at the two-week visit, women are provided with the hand-held remote control and provided with training about the expansion process. Training is one-on-one with the surgeon and takes approximately 5 minutes. The patient is shown how to push the button, educated about the safety lockout features, and told to seek medical attention if there is excessive pain or changes in the wound such as gaping or redness. Training is supplemented with a take-home booklet, a product support phone helpline, and a product website if further information is required.

Patients are booked back into clinic every 4 weeks to check on progress. When expansion is complete, they are booked for the surgical procedure to replace the expander with their final implant. Expansion is complete when the expander has reached its full capacity (400cc for the small size, 600 cc for the medium size and 800cc for the large size) or when the patient has reached their desired breast size if this occurs earlier. The size of the expander largely depends on the patient's previous breast size, as this determines the size of the available skin pocket to hold the expander.

The surgeon will be performing the surgery and seeing the patient at the followup visits. Expansion will be carried out by the patient using the hand-held remote. The general anaesthetic for surgery will be proved as per the routine protocols at GCHealth. The actual drug doses, frequency, and mode of administration will be at the discretion of the anaesthetist of the day. Immediate postop routine analgesia includes regular paracetamol plus oral opiates as required (typically Endone 5mg q6h prn) with additional analgesia as charted by the acute pain team, which is part of the clinical pathway. After discharge home and through the expansion period, patients do not need anything more than paracetamol prn.

The expansion is initiated by the patient depending on their own comfort. 10cc of gas is released each time the button on the remote is pressed, there is a 3-hour lockout between doses, and a 24-hour lockout after the third dose. Other than this there is no 'schedule' and patients can expand as quickly or slowly as they wish. Adherence is not expected to be an issue as patients who undergo this surgery are usually very motivated to complete the expansion as part of their breast reconstruction journey. The AirXpander has a maximum duration of 6 months after insertion (the same as for saline expanders) but many patients have completed expansion at the first 4 week check. Previous experience with saline expanders show that non-completion of expansion is most commonly due to unexpected significant health events that make the patient unfit for further surgery, and not because the patient does not comply with treatment.

The device is a standard expander shell, but without a saline injection port. Instead, it contains a small canister containing compressed carbon dioxide which is actuated through a hand-held remote controller. With saline expanders, patients receive 100 mL injections of saline through the skin into the injection port. With the AirXpander, 10mL is released each time the button on the remote is pressed, capped at 30mL per 24 hours. Thus the previous 100mL volume can be delivered in 3.3 days. Previous studies also show that expansion times are shorter because it is possible to expand 210mL over 7 days- more than twice as much as a 100mL saline injection. So patients can expand faster or slower than the usual saline expansion schedule, in the comfort of their own homes, without further clinic visits or skin punctures. Breast size can also be very accurately calibrated because the AirXpander allows breast size to be changed by increments of 10mL, and patients can pause expansion for a few days to 'live with' their chosen breast size and decide if they wish to keep expanding or stop.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Safety- device related events, breast related events, other adverse events Known/possible adverse events are the same as for existing saline expander. Device-related events- failure to expand, device rupture, device leak Breast-related events- infection, bleeding, flap necrosis, impaired wound healing, seroma Other adverse events- pain beyond expected, venous thrombosis, pneumonia, cardiac event These events will be gathered from the electronic medical record and cross-checked with complications logged in the monthly unit morbidity and mortality audit.

Timepoint [1]

12 months (1 year) from first insertion of device

Secondary outcome [1]

Efficacy- device success Measured as a binary (yes/no) information gained from electronic medical record

Timepoint [1]

12 months (1 year) from first insertion of device

Secondary outcome [2]

Device success- time to completion of expansion Measured in days from time of first surgery, information gained from electronic medical record

Timepoint [2]

12 months (1 year) from insertion of device

Secondary outcome [3]

Device success- time to second stage procedure Measured in days from time of first surgery, information gathered from electronic medical record

Timepoint [3]

12 months (1 year) from insertion of device

Eligibility

Key inclusion criteria

1) participant requires immediate or delayed breast reconstruction using expander implant
2) participant is over the age of 18

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) participant is unable to give informed consent

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Prospective consecutive case series

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Number of participant = 50.
This number has been chosen based on current patient numbers in the study unit and the previous largest single-surgeon trial in Australia (n=22)

Quantitative data (number of days) will be analysed with descriptive statistics. These will include measures of central tendency (mean, median, mode) and spread (standard deviation). Individual adverse effects and device success/failure will be described qualitatively.

Recruitment

Recruitment status

Withdrawn

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

Product withdrawn from market

Date of first participant enrolment

Anticipated

29/04/2019

Actual

Date of last participant enrolment

Anticipated

27/04/2020

Actual

Date of last data collection

Anticipated

26/04/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Robina Hospital - Robina

Recruitment hospital [2]

Gold Coast University Hospital - Southport

Recruitment postcode(s) [1]

4226 - Robina

Recruitment postcode(s) [2]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Gold Coast Health

Address [1]

1 Hospital Blvd, Southport, QLD 4215

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Gold Coast Breast Services

Address

1 Hospital Blvd, Southport, QLD 4215

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Gold Coast Hospital and Health District Human Research Ethics Committee

Ethics committee address [1]

1 Hospital Boulevard
Southport, QLD, 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/03/2019

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

A two-stage tissue expander–to-implant procedure is the most common implant-based reconstructive method, and accounted for 2868 procedures in Australia in 2016. The saline implant with self-sealing port was patented in 1980 by Radovan and requires serial bolus injections of saline to be administered by a clinician every few weeks after surgery. This process can be uncomfortable, lengthy, and logistically challenging for patients and clinics due to the need for ongoing recurrent appointments.

The AeroForm® tissue expander (AirXpanders® Inc., Palo Alto, California) is a remote-controlled, carbon dioxide–filled breast tissue expander. It was designed to provide women with a gradual, needle-free, controlled, and faster method of completing the expansion process. This system is composed of an implantable tissue expander containing a reservoir of compressed carbon dioxide, and an external hand-held remote control. The patient uses the controller to activate a valve within the reservoir to release carbon dioxide into the expander, eliminating the necessity for repeated injections and the associated clinic visits. The device is programmed to allow patient dosing in increments of 10 cm3. Multiple safety mechanisms are incorporated into the device design; only one 10cm3 dose of carbon dioxide may be administered during a 3-hour period, and no more than three doses (30 cm3) of carbon dioxide may be given per day.

The AeroForm® expander demonstrated successful expansion within 2 weeks with no adverse effects in a sheep model, and the first human trials, conducted in Australia, demonstrated 100 percent success rates in the Patient-Activated Controlled Expansion I and II (pilot and extended pilot) trials. These were single-surgeon trials. These early trials, supported with additional data from the Australian Aspirin to Prevent Recurrent Venous Thromboembolism trial, provided the basis for successful Therapeutic Goods Administration approval of the device in Australia.

The only randomised, controlled trial, AeroForm® Patient Activated controlled tissue expander (XPAND) has been performed in the United States, showing statistically significant shorter expansion and reconstruction times compared to saline implant, non-inferiority for safety with a 10 percent margin, and high rates of patient-rated ease, convenience, and satisfaction.

The purpose of this study is to undertake the first multi-surgeon case series in Australia. AeroForm®  is already standard supply in Gold Coast Health, with very positive patient feedback about the convenience and comfort of patient-controlled inflation. However, it is very important to the surgeons of the unit that clinical outcomes are also satisfactory.

Trial website

Trial related presentations / publications

Public notes

Importantly, this trial is intended to be inclusive, reflecting real-world patients in a high volume breast unit. The inclusion and exclusion criteria have been kept to a minimum, in contrast to previously published trials which have often been restricted to populations which form a minority of our actual patients by excluding cancer indications, BMI >33, smokers, diabetics and so on. This may result in a wider range of treatment outcomes than previously published trials, but it is hoped that the information arising from this study will also be more realistic and applicable to the settings of other breast units around Australasia.

Contacts

Principal investigator

Name

A/Prof Rhea Liang

Address

Robina Hospital 2 Bayberry Lane, Robina, QLD 4226

Country

Australia

Phone

+61403449308

Fax

[email protected]

Contact person for public queries

Name

Rhea Liang

Address

Robina Hospital, 2 Bayberry Lane, Robina, QLD 4226

Country

Australia

Phone

+61403449308

Fax

[email protected]

Contact person for scientific queries

Name

Rhea Liang

Address

Robina Hospital, 2 Bayberry Lane, Robina, QLD 4226

Country

Australia

Phone

+61403449308

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• all of the individual participant data collected during the trial, after de-identification

What types of analyses could be done with individual participant data?

• for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?

From:
Start after first publication (anticipated ~December 2021)
End date 15 years later when data is destroyed as per institutional protocols ~April 2036

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• requirement to sign data access agreement

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1498	Study protocol					Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically