Last reviewed · How we verify
NCT06020573
Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection
NA trial testing Clip-on electrode with fiber optics in Breast Cancer in 24 participants. Completed in 29 July 2024.
29 July 2024
Quick facts
| Lead sponsor | Erbe Elektromedizin GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 26 September 2023 |
| Primary completion | 29 July 2024 |
| Estimated completion | 29 July 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Clip-on electrode with fiber optics
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Resection Margin — all drugs for Resection Margin →
Sponsor
Erbe Elektromedizin GmbH — full company profile →
Who can join
18 and older, female only, with Breast Cancer or Resection Margin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06020573
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Erbe Elektromedizin GmbH trials
Trials by the same sponsor.
- NCT07065214 — Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy · NA · recruiting
- NCT06249841 — Feasibility of Cryobiopsy from the Bile Duct - CRYLEO · NA · completed
- NCT05587491 — HybridAPC for Gastric Mucosal Ablation in Obese Patients. · NA · completed
- NCT03621319 — Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06020573 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erbe Elektromedizin GmbH
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06020573.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing