Intraoperative Tissue Identification by Analyzing Surgical Smoke

NCT04881331 | Completed

• 1 other identifier: R17096
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Surgical time

  During the procedure

• Complications

  30 days after surgery.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histologically confirmed primary malignancy of the breast

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

TAYS Hatanpää

Tampere, Pirkanmaa, 33900, Finland

Location

Related 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.

  PMID: 30366874 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Chief physician

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 11, 2021
• Study Start: October 9, 2019
• Primary Completion: December 26, 2019
• Study Completion: December 26, 2019
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)