Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)
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| First Received Date ICMJE | August 26, 2011 | ||||||||
| Last Updated Date | June 13, 2013 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Successful tissue expansion and exchange to a permanent breast implant unless precluded by a non-device related event [ Time Frame: 6 months ] [ Designated as safety issue: No ] The primary endpoint will be assessed when the subject has completed tissue expansion and had an exchange to permanent breast implants. Subjects not completing permanent breast implant procedure will be considered failures if the procedure could not be completed due to a device related event. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01425268 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
The safety of the device will be evaluated by the data collected on device related adverse events, serious device related adverse events, all adverse and serious adverse events (regardless of their relationship to the device), and device malfunctions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] All adverse events will be collected and reported during the time that the expander is implanted. All events will be reported and categorized based on their relationship to the device or procedure. All device malfunctions will be reported. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Patient Controlled Tissue Expansion for Breast Reconstruction | ||||||||
| Official Title ICMJE | AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction | ||||||||
| Brief Summary | This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy. |
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| Detailed Description | This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 138 | ||||||||
| Estimated Completion Date | March 2014 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted. 5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site. 6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes). 7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin). 8. Subject is currently participating in a concurrent investigational drug or device study. 9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted. 12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device. 13. Subject is pregnant or planning on becoming pregnant during the study period. 14. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely. |
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| Gender | Female | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01425268 | ||||||||
| Other Study ID Numbers ICMJE | CTP-0003 AirXpanders | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | AirXpanders, Inc. | ||||||||
| Study Sponsor ICMJE | AirXpanders, Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AirXpanders, Inc. | ||||||||
| Verification Date | June 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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