Intraoperative Tissue Identification by Analyzing Surgical Smoke (SurgiNose)

May 10, 2021 updated by: Niku Oksala, Tampere University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination rate of healthy tissue types encountered during surgery
Time Frame: During the procedure

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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