Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection

Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (ELINORE)

This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection.

In consequence the data should also be taken to adapt technical features according to the findings. The study results will be utilized to design and to calculate the sample size for future pivotal studies after finalizing this study and to adapt the technical features of the system and/ or device. In the future pivotal study, the effectiveness of method and the reduction in R1 resection rate will be assessed with the final goal to provide continuous or real-time information about the tissue type that is currently cut.

The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.

After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. During the second visit (V2) they will receive the treatment procedure with the investigational medical device (IMD). The follow up visit (V3) will be performed up to 7 days after the treatment procedure at the day of discharge from the hospital.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Resection Margin
• Intervention / Treatment: Device: Clip-on electrode with fiber optics

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Department for Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site)
2. Solid tumor size ≥ 15 mm at screening, on sonography imaging
3. Breast conserving surgery
4. ≥ 18 years of age
5. Ability to provide written informed consent

Exclusion Criteria:

1. Neoadjuvant chemotherapy
2. Bilateral breast conserving surgery
3. Invasive lobular carcinoma, DCIS, LCIS
4. Suspicion of extensive DCIS component of NST tumor
5. Diagnosis of recurrent breast cancer
6. Previous radiotherapy
7. Patient is pregnant or lactating
8. Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator
9. According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intraoperative detection of light signals during electrosurgical breast cancer resection; Participants undergo electrosurgical breast cancer resection while light signals are detected intraoperatively	Device: Clip-on electrode with fiber optics; The device will be used for tumor resection of breast cancer and for the collection of optical data that could be ultimately used for providing additional information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, feasibility and performance	The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.	11 days

Collaborators and Investigators

• Sponsor: Erbe Elektromedizin GmbH
• Investigators: Principal Investigator: Markus Hahn, Prof.Dr. Med., Department for Women's Health, Tuebingen, Germany

Publications and helpful links

General Publications

• Spether D, Scharpf M, Hennenlotter J, Schwentner C, Neugebauer A, Nussle D, Fischer K, Zappe H, Stenzl A, Fend F, Seifert A, Enderle M. Real-time tissue differentiation based on optical emission spectroscopy for guided electrosurgical tumor resection. Biomed Opt Express. 2015 Mar 24;6(4):1419-28. doi: 10.1364/BOE.6.001419. eCollection 2015 Apr 1.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Breast Neoplasms; Margins of Excision
• Other Study ID Numbers: 768/2022MP1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No