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Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.
ClinicalTrials.gov Identifier:
NCT01425268
First received: August 26, 2011
Last updated: May 23, 2017
Last verified: May 2017
Results First Received: February 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Device: AeroForm Tissue Expansion
Procedure: Saline Tissue Expansion

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited were current patients at the investigator's practice who were scheduled to undergo two-stage breast reconstruction between November 2011 - December 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AeroForm Tissue Expansion

AeroForm Tissue Expansion inflation with carbon dioxide by remote control

AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.

Saline Tissue Expansion

Saline Tissue Expansion inflated by needle injections of saline

Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.


Participant Flow:   Overall Study
    AeroForm Tissue Expansion   Saline Tissue Expansion
STARTED   106 [1]   52 [2] 
COMPLETED   98   52 
NOT COMPLETED   8   0 
Withdrawal by Subject                2                0 
Sponsor Decision                5                0 
Physician Decision                1                0 
[1] 106 Subjects Randomized to AeroForm Arm / 98 Subjects Treated (Implanted)
[2] 52 Subjects Randomized to Saline Arm / 52 Subjects Treated (Implanted)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AeroForm Tissue Expansion

AeroForm Tissue Expansion inflation with carbon dioxide by remote control

AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.

Saline Tissue Expansion

Saline Tissue Expansion inflated by needle injections of saline

Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.

Total Total of all reporting groups

Baseline Measures
   AeroForm Tissue Expansion   Saline Tissue Expansion   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   52   150 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      92  93.9%      49  94.2%      141  94.0% 
>=65 years      6   6.1%      3   5.8%      9   6.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.9  (9.83)   51.1  (9.88)   49.7  (9.87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      98 100.0%      52 100.0%      150 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   98   52   150 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event   [ Time Frame: 12 months ]

2.  Secondary:   Expansion Days   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Device improvements occurred during the study with later subjects completing the study with a revised version of the device.

Results include all subjects treated in the study, regardless of device version.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Affairs
Organization: AirXpanders
phone: 650-390-9000 ext 9003
e-mail: kkelley@airxpanders.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT01425268     History of Changes
Other Study ID Numbers: CTP-0003 AirXpanders
Study First Received: August 26, 2011
Results First Received: February 26, 2017
Last Updated: May 23, 2017