Intraoperative Tissue Identification by Analyzing Surgical Smoke

Breast Cancer Clinical Trial

— SurgiNose  

Official title:

Intraoperative Tissue Identification by Analyzing Surgical Smoke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881331
• Other study ID #: R17096
• Status: Completed
• Start date: October 9, 2019
• Est. completion date: December 26, 2019

Study information

• Verified date: May 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 26, 2019
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed primary malignancy of the breast

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Analysis of electrosurgical smoke.
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.

Locations

Country	Name	City	State
Finland	TAYS Hatanpää	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. — View Citation

Outcome

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