In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Lymphoma of Lymph Nodes of Inguinal Region
- Sponsor
- Philips Healthcare
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Differentiation between nerve tissue and its surrounding tissue
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Patients that have provided a signed informed consent
- •Patients ≥ 18 years old
Exclusion Criteria
- •Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
Outcomes
Primary Outcomes
Differentiation between nerve tissue and its surrounding tissue
Time Frame: Day 0
Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations