ORASIS in Breast Reconstruction

Conditions

• Breast Cancer
• Breast Reconstruction
• DIEP Flap

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Use of ORASIS Device — DEVICE
  The study intervention is the use of the ORASIS device during microsurgical anastomosis formation in DIEP flap breast reconstruction procedures. 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 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 demonstrated compliance to international quality standards. The manufacturer has successfully implemented the ISO 9001 Quality Management System across all operational areas following a comprehensive audit process, that supports compliance with FDA 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 Details

The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in DIEP (Deep Inferior Epigastric Perforator) 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.

Key Dates

Start date

Dec 31, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• No Intervention: Control Arm
  In the control arm, surgeons will perform two microsurgical anastomoses without the use of ORASIS in either bilateral or unilateral 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) and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures.
• Experimental: ORASIS Arm
  In the ORASIS arm, surgeons will perform two microsurgical anastomoses with the use of ORASIS in either bilateral or unilateral 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.

Primary Outcome Measure

Mean anastomosis time (minutes) [ Time Frame: From first suture placement to anastomosis completion ]

Central Contacts

• Joey Liang
  4252097705
  [email protected]
• Ash Patel, MB ChB
  [email protected]

Locations (2)

Find similar trials in Durham, NC

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