Optical Detection of Peripheral Nerve Bundles During Surgery (NerveSpect)
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.
Malignant Lymphoma of Lymph Nodes of Inguinal Region
Malignant Lymphoma of Lymph Nodes of Axillary
Malignant Lymphoma of Lymph Nodes of the Cervix
Carcinoma of Parotid Gland
Colon Rectal Cancer Tubulovillous Adenocarcinoma
Tumor of Soft Tissue of Head, Face and Neck
Procedure: Surgical resection
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study|
- Differentiation between nerve tissue and its surrounding tissue [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
Procedure: Surgical resection
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.
The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.
The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731379
|Contact: Theo Ruers, MD||+31 020 firstname.lastname@example.org|
|Contact: Koert Kuhlmann, MD||:+31(0)20 email@example.com|
|Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1066 CX|
|Contact: Jarich Spliethoff, MSc +31 020 5127491 firstname.lastname@example.org|
|Contact: Niels Langhout, MSc +31 020 5122316 email@example.com|
|Principal Investigator:||Theo Ruers, MD||Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis|