Trials / Recruiting
RecruitingNCT05003635
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Maastricht University Medical Center · Academic / Other
- Sex
- Female
- Age
- 23 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EVEBRA device | Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day. |
Timeline
- Start date
- 2021-07-12
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
- First posted
- 2021-08-12
- Last updated
- 2022-08-03
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05003635. Inclusion in this directory is not an endorsement.