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.

NCT07670754

ORASIS in Breast Reconstruction

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Duke University
~30 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Use of ORASIS Device

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean anastomosis time (minutes)
Measured over From first suture placement to anastomosis completion
+1 more outcome measured
DIEP Flap
Breast Reconstruction
Breast Cancer
2 sites across 1 states
North Carolina2

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  • 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.