ORASIS Device for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the ORASIS device to determine if it can improve surgery results for women undergoing breast reconstruction with the DIEP flap technique. Researchers aim to find out if ORASIS can help surgeons work faster and reduce errors during this delicate procedure. Participants may qualify if they have had a mastectomy and are planning to undergo or have already started a DIEP flap breast reconstruction.
As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes for future patients.
What prior data suggests that the ORASIS device is safe for breast reconstruction?
Research has shown that the ORASIS device is being tested in breast reconstruction surgeries to potentially make the process faster and more accurate. As with any surgery, potential risks exist, including flap failure, the need for additional surgery, and infections at the surgery site. These concerns are common in breast reconstruction surgeries.
The surgery type, DIEP flap reconstruction, is generally considered safe. Studies indicate a low failure rate of about 4.3%, which compares favorably to other techniques. While risks like infection or minor issues exist, they are not unusually high for surgeries of this nature.
In summary, while using the ORASIS device in these surgeries carries risks, the overall safety is comparable to other similar procedures.12345Why are researchers excited about this trial?
Researchers are excited about the ORASIS device because it could transform breast reconstruction surgeries by enhancing the precision and success rate of microsurgical anastomoses. Unlike the standard of care that relies solely on surgeons' skills to connect blood vessels, the ORASIS device aims to assist in these delicate procedures, potentially reducing complications and improving healing. This innovative approach could lead to more consistent outcomes and faster recovery times for patients undergoing DIEP flap reconstruction.
What evidence suggests that the ORASIS device is effective for breast reconstruction?
Studies have shown that DIEP flap surgery, a method used for breast reconstruction, succeeds 96% to 99% of the time, indicating high patient satisfaction with the results. In this trial, one group of participants will undergo surgery using the ORASIS device, which research suggests can speed up the process and improve blood vessel connections. The ORASIS device helps surgeons work more efficiently. Although specific data on ORASIS is not yet available, it aims to make the surgery more precise and faster, potentially leading to even better patient outcomes. Another group will undergo the standard procedure without the ORASIS device.12678
Are You a Good Fit for This Trial?
This trial is for adults undergoing DIEP flap breast reconstruction surgery, often after breast cancer. Specific inclusion and exclusion criteria are not listed, but generally participants must be eligible for this type of reconstructive surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Participants undergo DIEP flap breast reconstruction with or without the use of ORASIS during microsurgical anastomosis
Immediate Postoperative Monitoring
Participants are monitored for postoperative complications such as flap failure, re-operation, and surgical site infection
Follow-up
Participants are monitored for safety and effectiveness after the surgical procedure, including surgeon surveys and assessment of surgical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- ORASIS Device
Trial Overview
The study is testing the ORASIS device during microsurgery in DIEP flap breast reconstruction to see if it helps surgeons work faster and improves surgical connections between blood vessels.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In the ORASIS arm, surgeons will perform two microsurgical anastomoses with the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the treatment arm, ORASIS will only be used in the first microsurgical anastomosis performed in each bilateral DIEP flap reconstruction; only the breast reconstructed with the use of ORASIS will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
In the control arm, surgeons will perform two microsurgical anastomoses without the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the control arm, only the first microsurgical anastomosis for each bilateral DIEP flap reconstruction will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) perforators and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Citations
NCT07670754 | ORASIS in Breast Reconstruction
The investigators hypothesize that the use of ORASIS will decrease the amount of time needed to perform microsurgical anastomoses, reduce ...
deep inferior epigastric perforator flap vs. implant-based ...
The included studies suggest that DIEP-flaps are cost-effective compared with implant-based breast reconstruction when the applied cost-effectiveness thresholds ...
Evaluating the efficacy and safety of various flaps in ... - PMC
In terms of total flap loss, the TUG flap showed the highest SUCRA value (89.6%), followed by the TMG flap (64.8%). For donor site wound ...
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naturalbreastreconstruction.com
naturalbreastreconstruction.com/blog/what-are-the-long-term-results-of-diep-flap-surgeryWhat Are the Long-Term Results of DIEP Flap Surgery?
DIEP flap surgery has a success rate between 96% and 99%. In other words, most patients who undergo this procedure are satisfied with their ...
Cost-volume analysis of deep inferior epigastric artery ...
Deep inferior epigastric artery perforator flap utilization increased from 31% in 2016 to 40% in 2019 (P < .001) among inpatient breast reconstructions.
Deep inferior epigastric perforator (DIEP) flap safety profile ...
This study aims to compare the outcomes of performing DIEP flap breast reconstruction in slim and non-slim body mass index (BMI) patients.
The Impact of Radiotherapy on the Outcomes of Deep Inferior ...
Irradiated breasts carry a substantial risk of infection, stromal atrophy, hyperpigmentation, flap fibrosis, and breast asymmetry, all of which ...
The Risks & Benefits of DIEP Flap Surgery After a ...
While DIEP flap reconstruction is considered a safe, life-affirming procedure for many women, there are potential risks and complications, as ...
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