Intraoperative Tissue Identification by Analyzing Surgical Smoke (SurgiNose)

SurgiNose is a single-center, non-randomized feasibility study aiming to evaluate the feasibility of intraoperative tissue analysis using differential mobility of surgical smoke generated with electrocautery.

Patients receive standard-of-care breast conserving surgery.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Analysis of electrosurgical smoke.

Detailed Description

The increasing number of breast cancer survivors and their longevity has emphasized the importance of aesthetic and functional outcomes of cancer surgery and increased pressure for the surgical treatment to achieve negative margins with minimal removal of healthy tissue.

Surgical smoke has been successfully utilized in tissue identification in laboratory conditions by using a system based on differential mobility spectrometry (DMS) that could provide a seamless margin assessment method.

In this study, a DMS-based tissue smoke analysis system will be used intraoperatively in 20 breast cancer surgeries to assess its feasibility in tissue identification. The effect of the system on complications and duration of surgeries is also studied. The surgeries are recorded with a head-worn camera system for visual annotation of the operated tissue types to enable classification of the measurement files by supervised learning.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33900
      • TAYS Hatanpää

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast conserving surgery for histologically confirmed malignancy of the breast. There is no upper limit for participation.

Description

Inclusion Criteria:

• Histologically confirmed primary malignancy of the breast

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrimination rate of healthy tissue types encountered during surgery	The device records a molecular spectrum of the surgical smoke every time the device is activated. The tissues are annotated using head-mounted camera that records video footage from the viewpoint of the surgeon. The primary outcome of the the study is the ability of the device to correctly classify healthy tissues that are encountered during breast surgery including fat tissue, glandular tissue, connective tissue, muscle tissue, dermis. The accuracy is cross-validated using leave-one-out cross-validation and is reported as correct classification rate (CCR) %.	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical time	The duration of surgical procedures when the device is used. Institutional average procedure duration is used for comparison.	During the procedure
Complications	Complications of surgery in the follow-up period of 30 days.	30 days after surgery.

Collaborators and Investigators

• Sponsor: Tampere University Hospital

Publications and helpful links

General Publications

• Sutinen M, Kontunen A, Karjalainen M, Kiiski J, Hannus J, Tolonen T, Roine A, Oksala N. Identification of breast tumors from diathermy smoke by differential ion mobility spectrometry. Eur J Surg Oncol. 2019 Feb;45(2):141-146. doi: 10.1016/j.ejso.2018.09.005. Epub 2018 Oct 15.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): December 26, 2019
• Study Completion (Actual): December 26, 2019

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: R17096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No