NCT04881331

Intraoperative Tissue Identification by Analyzing Surgical Smoke

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-09
• Primary completion: 2019-12-26
• Completion: 2019-12-26
• First posted: 2021-05-11
• Last updated: 2021-05-11

Locations

1 site across 1 country: Finland