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SurgiNose: Intraoperative Tissue Identification by Analyzing Surgical Smoke

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04881331
Collaborator
(none)
20
Enrollment
1
Location
2.6
Actual Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Analysis of electrosurgical smoke.

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 Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Intraoperative Tissue Identification by Analyzing Surgical Smoke
Actual Study Start Date :
Oct 9, 2019
Actual Primary Completion Date :
Dec 26, 2019
Actual Study Completion Date :
Dec 26, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Surgical time [During the procedure]

    The duration of surgical procedures when the device is used. Institutional average procedure duration is used for comparison.

  2. Complications [30 days after surgery.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Histologically confirmed primary malignancy of the breast
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 TAYS Hatanpää Tampere Pirkanmaa Finland 33900

Sponsors and Collaborators

  • Tampere University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Niku Oksala, Professor of Surgery, Chief physician, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT04881331
Other Study ID Numbers:
  • R17096
First Posted:
May 11, 2021
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 11, 2021