Breast CancerNCT06020573
Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection
A study testing Clip-on electrode with fiber optics in people with Breast Cancer and Resection Margin, run by Erbe Elektromedizin GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Resection Margin
- What is being tested?
- Clip-on electrode with fiber optics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 26 Sep 2023to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Breast Cancer, Resection Margin
- Being tested
- Clip-on electrode with fiber optics
- Medical subject headings
- Breast Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clip-on electrode with fiber opticsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative detection of light signals during electrosurgical breast cancer resection | Other | Participants undergo electrosurgical breast cancer resection while light signals are detected intraoperatively Receives: Device: Clip-on electrode with fiber optics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start26 Sep 2023
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erbe Elektromedizin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Hahn, Prof.Dr. Med., Principal investigator, Department for Women's Health, Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020573
- Sponsor's protocol ID
- 768/2022MP1
- Status last verified
- Apr 2026
- First submitted
- 24 Aug 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25909025
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (ELINORE)
- ClinicalTrials.gov ID
- NCT06020573
- Acronym / sponsor ID
- 768/2022MP1
- Conditions
- Breast Cancer, Resection Margin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Erbe Elektromedizin GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative detection of light signals during electrosurgical breast cancer resection | Other | Device: Clip-on electrode with fiber opticsParticipants undergo electrosurgical breast cancer resection while light signals are detected intraoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Neoadjuvant chemotherapy
- Bilateral breast conserving surgery
- Invasive lobular carcinoma, DCIS, LCIS
- Suspicion of extensive DCIS component of NST tumor
- Diagnosis of recurrent breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clip-on electrode with fiber opticsThe 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. | Device | Intraoperative detection of light signals during electrosurgical breast cancer resection |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 25909025Spether 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Hahn, Prof.Dr. Med. principal investigator
Department for Women's Health, Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clip-on electrode with fiber optics in people with Breast Cancer and Resection Margin, run by Erbe Elektromedizin GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, feasibility and performance (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.