NCT03918317

A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to to determine the efficacy and side effect profile following radiation therapy for participants with the AeroForm device placed. The AeroForm device is FDA approved.

Detailed description

Primary objective: To assess the proportion of successful initial phase of tissue expander/implant based breast reconstructions (no reconstruction failure or unexpected return to the operating room) following post-mastectomy radiation therapy in participants with AeroFormplaced. Secondary objectives: * To evaluate the rate of successful exchange of tissue expander for implant * To evaluate the rate of reconstruction revisions * To evaluate CTCAE acute and chronic toxicity rates, infections and cosmetic outcomes * To evaluate dosimetry to treatment targets as well as organs at risk (heart, lungs) with AeroFormas compared to traditional reconstruction techniques. * To evaluate time to initiation of chemotherapy and/or radiotherapy. * To evaluate clinical outcomes-local recurrence, regional recurrence, distant metastases, survival * To evaluate participant breast reconstruction related QOL with the AirXpander AeroFormdevice This is a phase II trial evaluating the use of the intervention in participants with breast cancer undergoing post-mastectomy radiation therapy in order to define the toxicity profile and associated subsequent successful surgical reconstruction rate

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	AirXpanders AeroFormtissue expander	The AeroFormdevice will be placed in an immediate fashion at the time of mastectomy in a submuscular, prepectoral or dual-plane approach. The tissue expander will be minimally inflated intraoperatively to minimize dead space and while facilitating tension free closure. Participants will undergo standard postoperative management, and will be given instructions on utilization of the device, including daily expansion until desired volume is reached as determined b surgeon and participant agreement.

Timeline

• Start date: 2019-07-15
• Primary completion: 2021-06-01
• Completion: 2022-06-01
• First posted: 2019-04-17
• Last updated: 2019-08-13

Regulatory

• FDA-regulated device study