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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Resection Margin Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department for Women's Health

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)
Solid tumor size ≥ 15 mm at screening, on sonography imaging
Breast conserving surgery
≥ 18 years of age
Ability to provide written informed consent

Exclusion criteria

Neoadjuvant chemotherapy
Bilateral breast conserving surgery
Invasive lobular carcinoma, DCIS, LCIS
Suspicion of extensive DCIS component of NST tumor
Diagnosis of recurrent breast cancer
Previous radiotherapy
Patient is pregnant or lactating
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
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

Treatment and study plan

Clip-on electrode with fiber optics

Device

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.

Primary outcomes

Safety, feasibility and performance

Time frame: 11 days

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.

Sponsors and collaborators

Lead sponsor

Erbe Elektromedizin GmbH

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Aug 31, 2023
Registry last updated: Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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