Optical Detection of Peripheral Nerve Bundles During Surgery (NerveSpect)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01731379|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment|
|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|
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.
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||October 2015|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731379
|Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis|
|Amsterdam, Noord-Holland, Netherlands, 1066 CX|
|Principal Investigator:||Theo Ruers, MD||Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis|