ORASIS in Breast Reconstruction

NCT07670754 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00118006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

DIEP Flap; Breast Reconstruction; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Mean anastomosis time (minutes)

  Total anastomosis time will be defined as the number of minutes from first suture placement to anastomosis completion.

  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.

  From pedicle transection to anastomosis completion

Secondary Outcomes (5)

• Mean number of interruptions per procedure

  From beginning of microsurgical anastomosis to end of microsurgical anastomosis

• Mean NASA-TLX (Task Load Index) score

  From beginning of microsurgical anastomosis to end of microsurgical anastomosis

• Mean Surgical Assessment Metric Scale (SAMS) overall scores

  From beginning of microsurgical anastomosis to end of microsurgical anastomosis

• Surgeon Survey

  Within 1 month after conclusion of DIEP flap surgery procedure

• Incidence of postoperative complications 0-48 hours after procedure

  Within 48 hours after DIEP flap surgery

Other Outcomes (2)

• Estimated cost difference per case (economic impact metrics)

  During the entirety of the DIEP flap procedure

• Number of surgeons per case

  During the entirety of the DIEP flap procedure

Study Arms (2)

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).

Device: Use of ORASIS Device

Interventions

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.

ORASIS Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Joey Liang

CONTACT

4252097705; joey.liang@duke.edu

Ash Patel, MB ChB

CONTACT

ash.patel@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)