JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06020573

Studienbeginn:
September 2023

Letztes Update:
26.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Erbe Elektromedizin GmbH

Collaborator:
-

Studienleiter

Markus Hahn, Prof.Dr. Med.
Principal Investigator
Department for Women's Health, Tuebingen, Germany

Kontakt

Vanessa Hartmann
Kontakt:
Phone: +4970717552850
E-Mail: vanessa.hartmann@erbe-med.com» Kontaktdaten anzeigen

Gabriela Soares
Kontakt:
Phone: +4970717552976
E-Mail: gabriela.soares@erbe-med.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department for Women's Health
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Markus Hahn, Prof. Dr. med» Ansprechpartner anzeigen

Studien-Informationen

Brief 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. 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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