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OpenTrials
Completed

NCT Number: NCT04881331

Intraoperative Tissue Identification by Analyzing Surgical Smoke

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

TAYS Hatanpää

Tampere, Pirkanmaa, 33900, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed primary malignancy of the breast

Exclusion criteria

-

Treatment and study plan

Analysis of electrosurgical smoke.

Other

Patients undergo standard of care surgical removal of the malignant breast tumor. Electrosurgical knife is used to cut tissues according to standard practice. Fraction of the surgical smoke is captured for analysis and video record of the point of view of the surgeon is captured with a head-mounted camera.

Primary outcomes

  1. 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) %.

Secondary outcomes

  1. 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.

  2. Complications

    Time frame: 30 days after surgery.

    Complications of surgery in the follow-up period of 30 days.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Acronym: SurgiNose

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 11, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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