Optical Detection of Peripheral Nerve Bundles During Surgery

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.

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Key information

Conditions

Malignant Lymphoma of Lymph Nodes of Inguinal Region Carcinoma of Parotid Gland Colon Rectal Cancer Tubulovillous Adenocarcinoma Disease Attributes Facies Head and Neck Neoplasms Malignant Lymphoma of Lymph Nodes of Axillary Malignant Lymphoma of Lymph Nodes of the Cervix Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Parotid Diseases Parotid Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Glycoprotein IV Deficiency Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases Tumor of Soft Tissue of Head, Face and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, 1066 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: lymph node dissection, resection of parotid gland, rectal surgery, soft tumor resection

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

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Collaborators

Philips Electronics Nederland B.V. acting through Philips CTO organization

Registry information

Official study title

In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study

Acronym: NerveSpect

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Nov 21, 2012
Registry last updated: Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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