ORASIS Device in Breast Reconstruction
This study is looking at a new device called ORASIS during breast reconstruction surgery. Specifically, it's for women having a type of breast reconstruction called DIEP flap, which uses tissue from your belly. The ORASIS device helps with irrigation (washing) and suction during a delicate part of the surgery where tiny blood vessels are reconnected (microsurgical anastomoses). Researchers believe using ORASIS will make the surgery faster, reduce interruptions for the surgeon, and improve the quality of these connections. You might be able to join if you are a woman, 18 or older, and are having DIEP flap breast reconstruction after a mastectomy for breast cancer or to prevent it. The study aims to enroll 30 participants, but its current status is unclear.
- Study design
- This is an interventional study involving 30 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes, like anastomosis time and ischemia time, are measured during the surgery itself.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ORASIS in Breast Reconstruction
At a glance
Conditions
Where it's being run
2 sites across 1 statesWho to contact
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What this trial measures
- Mean anastomosis time (minutes)From first suture placement to anastomosis completion
Total anastomosis time will be defined as the number of minutes from first suture placement to anastomosis completion.
- Mean ischemia time (minutes)From pedicle transection to anastomosis completion
Total ischemia time will be defined as the number of minutes from flap division to flap reperfusion.