ORASIS in Breast Reconstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University
About this trial
The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction and its potential effects on surgical precision, surgeon efficiency, and anastomosis outcomes. The investigators hypothesize that the use of ORASIS will decrease the amount of time needed to perform microsurgical anastomoses, reduce interruptions for irrigation and suction, and increase the quality of anastomoses in DIEP flap breast reconstruction.
Eligibility criteria
Qualifiers
Female Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction patients who have received a prior mastectomy (either unilateral or bilateral) on the breast undergoing reconstruction
Patients who received mastectomies for oncologic or prophylactic indications
Patients receiving either immediate or delayed DIEP flap breast reconstruction
Age 18 or older at the time of patient consent and DIEP flap surgery
Disqualifiers
None
Trial design
Treatments tested in this trial
- Use of ORASIS Device
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov