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NCT Number: NCT07670754

ORASIS in Breast Reconstruction

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.

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Key information

Conditions

DIEP Flap Breast Cancer Breast Diseases Breast Neoplasms Breast Reconstruction Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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

Exclusion:

  • 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

Treatment and study plan

Use of ORASIS Device

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Mean number of interruptions per procedure

    Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis

    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.

  2. Mean NASA-TLX (Task Load Index) score

    Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis

    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.

  3. Mean Surgical Assessment Metric Scale (SAMS) overall scores

    Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis

    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.

  4. Surgeon Survey

    Time frame: Within 1 month after conclusion of DIEP flap surgery procedure

    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.

  5. Incidence of postoperative complications 0-48 hours after procedure

    Time frame: Within 48 hours after DIEP flap surgery

    Notable complications include flap failure, re-operation/take-back and wound dehiscence, seroma, hematoma, and surgical site infection.

Other outcomes

  1. Estimated cost difference per case (economic impact metrics)

    Time frame: During the entirety of the DIEP flap procedure

    Based on average operating room (OR) time cost for plastic surgery procedures at Duke (dollars per minute).

  2. Number of surgeons per case

    Time frame: During the entirety of the DIEP flap procedure

    Number of surgeons per case, stratified by level of training (i.e. 1 vs 2 microsurgeons required +/- residents). For example, allowing a microsurgeon to perform the anastomosis alone as opposed to a co-surgeon case would reduce operative costs.

Study contacts

Contact information is provided by the study sponsor or research team.

Ash Patel, MB ChB

CONTACT

[email protected]

Joey Liang

CONTACT

[email protected]

4252097705

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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