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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative detection of light signals during electrosurgical breast cancer resection | Other | Participants undergo electrosurgical breast cancer resection while light signals are detected intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Hahn, Prof.Dr. Med. | Department for Women's Health, Tuebingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for Women's Health | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25909025 | Background | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |