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| Name | Class |
|---|---|
| Philips Electronics Nederland B.V. acting through Philips CTO organization | INDUSTRY |
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Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.
The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.
Primary Objective:
The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.
Secondary Objective:
During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical resections | Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical resection | Procedure | Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. |
| Measure | Description | Time Frame |
|---|---|---|
| Differentiation between nerve tissue and its surrounding tissue | Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
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Eligible patients are patients of the Netherlands Cancer Institute (NKI-AvL), who are scheduled for an elective inguinal, axillary or cervical lymph node dissection, or parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
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| Name | Affiliation | Role |
|---|---|---|
| Theo Ruers, MD | Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis | Amsterdam | North Holland | 1066 CX | Netherlands |
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|
| ID | Term |
|---|---|
| D010307 | Parotid Neoplasms |
| D019066 | Facies |
| C564245 | Platelet Glycoprotein IV Deficiency |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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