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

NCT03918317 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-08-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Chirag Shah · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2021-06-01
Completion
2022-06-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918317 on ClinicalTrials.gov