Intraoperative Tissue Identification by Analyzing Surgical Smoke

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04881331
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-10-09
• Primary Completion: 2019-12-26
• Study Completion: 2019-12-26
• Status Verified: 2021-05
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Study First Posted: 2021-05-11
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Histologically confirmed primary malignancy of the breast

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discrimination rate of healthy tissue types encountered during surgery	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) %.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

TAYS Hatanpää; 🇫🇮 Tampere, Pirkanmaa, Finland