NCT01731379

Optical Detection of Peripheral Nerve Bundles During Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Philips Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-01-01
• Completion: 2015-10-01
• First posted: 2012-11-21
• Last updated: 2015-11-03

Locations

1 site across 1 country: Netherlands