Optical Detection of Peripheral Nerve Bundles During Surgery

Carcinoma of Parotid Gland Clinical Trial

— NerveSpect  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731379
• Other study ID #: NL 40893.031.12
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: November 2, 2015
• Start date: December 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma of Parotid Gland
• Colon Rectal Cancer Tubulovillous Adenocarcinoma
• Colorectal Neoplasms
• Lymphoma
• Malignant Lymphoma of Lymph Nodes of Axillary
• Malignant Lymphoma of Lymph Nodes of Inguinal Region
• Malignant Lymphoma of Lymph Nodes of the Cervix
• Soft Tissue Neoplasms
• Tumor of Soft Tissue of Head, Face and Neck

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Philips Healthcare	Philips Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differentiation between nerve tissue and its surrounding tissue	Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations	Day 0	No