DIEP FlapNCT07670754
ORASIS in Breast Reconstruction
A study testing Use of ORASIS Device in people with DIEP Flap and Breast Reconstruction, run by Duke University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- DIEP Flap, Breast Reconstruction, Breast Cancer
- What is being tested?
- Use of ORASIS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of any prior tissue expander placement or breast reconstruction on the breast undergoing DIEP flap reconstruction
- Patients receiving DIEP flap breast reconstruction for indications other than oncologic or prophylactic post-mastectomy breast reconstruction
- Under the age of 18 at the time of patient consent or DIEP flap surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ash Patel, MB ChB contact
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Joey Liang, 425-209-7705, joey.liang@duke.edu
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
Joey Liang, 425-209-7705, joey.liang@duke.edu
About this study
Official title: ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled 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.
- Conditions
- DIEP Flap, Breast Reconstruction, Breast Cancer
- Being tested
- Use of ORASIS Device
- Keywords
- DIEP Flap, Breast Reconstruction, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of ORASIS DeviceDevice
The study intervention is the use of the ORASIS device during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction. ORASIS is a dual irrigation and suction device that can be placed in the surgical field during the formation of microsurgical anastomoses. The device was previously registered with the Food and Drug Administration (FDA) under registration number 878.4200; the device is currently not registered with the FDA as it is pending renewal. The device is manufactured by a partner company (Spectroplast/Ricoh UK) with compliance to international quality standards. The manufacturer has successfully implemented the ISO 9001 Quality Management System across operational areas following a comprehensive audit process that supports compliance with FDA Current Good Manufacturing Practice (cGMP) requirements (21 CFR Part 820) for Class I medical devices. Spectroplast/Ricoh UK is certified under FDA ISO 10993 standards for biological evaluation of medical devices.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | 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). |
| ORASIS Arm | Experimental | 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). Receives: Device: Use of ORASIS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean anastomosis time (minutes)
Total anastomosis time will be defined as the number of minutes from first suture placement to anastomosis completion.
Measured: From first suture placement to anastomosis completion
Mean ischemia time (minutes)
Total ischemia time will be defined as the number of minutes from flap division to flap reperfusion.
Measured: From pedicle transection to anastomosis completion
Secondary outcomes (5)
Mean number of interruptions per procedure
Interruptions will be defined as instances where the surgeon pauses for suction/irrigation in the control arm vs. automatic suction/irrigation in the ORASIS arm.
Measured: From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Mean NASA-TLX (Task Load Index) score
The NASA Task Load Index (NASA-TLX) is a validated tool to measure cognitive and physical workload for surgeons, reported as a score between 0 to 100.
Measured: From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Mean Surgical Assessment Metric Scale (SAMS) overall scores
The Surgical Assessment Metric Scale (SAMS) is a validated tool that assesses proficiency across key technical metrics such as suture placement, knot quality, and overall flow of the procedure on a scale of 1-5. Performed anastomoses will be recorded by the digital microscope, and the quality and precision of the anastomosis will be assessed by a blinded rater using the previously validated SAMS score checklist.
Measured: From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Surgeon Survey
A post-procedure survey (Likert scale) will be administered after each procedure assessing ease of use, surgeon perception of precision, and overall satisfaction with the ORASIS device.
Measured: Within 1 month after conclusion of DIEP flap surgery procedure
Incidence of postoperative complications 0-48 hours after procedure
Notable complications include flap failure, re-operation/take-back and wound dehiscence, seroma, hematoma, and surgical site infection.
Measured: Within 48 hours after DIEP flap surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIEP FlapStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This crossover study will utilize two arms: a control arm without the use of ORASIS and a treatment arm with the use of ORASIS. Each surgeon will serve as their own control by performing two anastomoses without the use of ORASIS and two anastomoses with the use of ORASIS. The order of procedures with or without ORASIS use will be randomized to minimize bias due to learning or fatigue. Blinding is not possible due to the visible use of the ORASIS device in the treatment arm of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670754
- Sponsor's protocol ID
- Pro00118006
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Confidentiality of subject data will be ensured by de-identification of subject data. During data collection, subject identifiers and relevant data elements will be recorded in the database. Then, study-specific identification numbers will be assigned to each subject. Prior to dissemination of any information in this database beyond the DUMC's secure servers or firewall, all identifiers will be stripped from the database and data will only be referenced by the study-specific identification numbers. The adequacy of the Duke Research Data Lifecycle will be evaluated and approved by the Surgery CRU and IT personnel prior to study conduct. Any publications or presentations that result from this research will not identify any subjects individually and will present data in aggregate form only. Data collected as part of this study will not be submitted to the FDA; data collected will only be used for publication as part of an assessment of device efficacy.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07670754
- Acronym / sponsor ID
- Pro00118006
- Conditions
- DIEP Flap, Breast Reconstruction, Breast Cancer
- Keywords
- DIEP Flap, Breast Reconstruction, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This crossover study will utilize two arms: a control arm without the use of ORASIS and a treatment arm with the use of ORASIS. Each surgeon will serve as their own control by performing two anastomoses without the use of ORASIS and two anastomoses with the use of ORASIS. The order of procedures with or without ORASIS use will be randomized to minimize bias due to learning or fatigue. Blinding is not possible due to the visible use of the ORASIS device in the treatment arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –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). |
| ORASIS Arm | Experimental | Device: Use of ORASIS DeviceIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of any prior tissue expander placement or breast reconstruction on the breast undergoing DIEP flap reconstruction
- Patients receiving DIEP flap breast reconstruction for indications other than oncologic or prophylactic post-mastectomy breast reconstruction
- Under the age of 18 at the time of patient consent or DIEP flap surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of ORASIS DeviceThe study intervention is the use of the ORASIS device during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction. ORASIS is a dual irrigation and suction device that can be placed in the surgical field during the formation of microsurgical anastomoses. The device was previously registered with the Food and Drug Administration (FDA) under registration number 878.4200; the device is currently not registered with the FDA as it is pending renewal. The device is manufactured by a partner company (Spectroplast/Ricoh UK) with compliance to international quality standards. The manufacturer has successfully implemented the ISO 9001 Quality Management System across operational areas following a comprehensive audit process that supports compliance with FDA Current Good Manufacturing Practice (cGMP) requirements (21 CFR Part 820) for Class I medical devices. Spectroplast/Ricoh UK is certified under FDA ISO 10993 standards for biological evaluation of medical devices. | Device | ORASIS Arm |
Primary outcome
Mean anastomosis time (minutes)
Time frame: 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)
Time frame: From pedicle transection to anastomosis completion
Total ischemia time will be defined as the number of minutes from flap division to flap reperfusion.
5 secondary outcomes
Mean number of interruptions per procedure
Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Mean NASA-TLX (Task Load Index) score
Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Mean Surgical Assessment Metric Scale (SAMS) overall scores
Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Surgeon Survey
Time frame: Within 1 month after conclusion of DIEP flap surgery procedure
Incidence of postoperative complications 0-48 hours after procedure
Time frame: Within 48 hours after DIEP flap surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Confidentiality of subject data will be ensured by de-identification of subject data. During data collection, subject identifiers and relevant data elements will be recorded in the database. Then, study-specific identification numbers will be assigned to each subject. Prior to dissemination of any information in this database beyond the DUMC's secure servers or firewall, all identifiers will be stripped from the database and data will only be referenced by the study-specific identification numbers. The adequacy of the Duke Research Data Lifecycle will be evaluated and approved by the Surgery CRU and IT personnel prior to study conduct. Any publications or presentations that result from this research will not identify any subjects individually and will present data in aggregate form only. Data collected as part of this study will not be submitted to the FDA; data collected will only be used for publication as part of an assessment of device efficacy.
Related trials for DIEP Flap
Not yet recruitingObservational study
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
Reconstructive Surgery, Flap Monitoring
Not yet recruitingPhase 3
Suzetrigine Post DIEP
Post-operative Pain, DIEP Flap Breast Reconstruction
Active, not recruitingObservational study
DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction
Breast Neoplasms, Breast Reconstruction
Not yet recruitingObservational study
A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy
Breast Reconstruction After Mastectomy
Recruiting
The Effect of a Post-operative Exercise Programme Versus Standard Care on Physical Fitness of Patients With Breast Cancer Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Reconstruction Surgery
Breast Cancer, Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ash Patel, MB ChB contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of ORASIS Device in people with DIEP Flap and Breast Reconstruction, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joey Liang (4252097705, joey.liang@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean anastomosis time (minutes) (time frame: From first suture placement to anastomosis completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.