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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01731379
Acronym
NerveSpect
Enrollment
35
Registered
2012-11-21
Start date
2012-12-31
Completion date
2015-10-31
Last updated
2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

spectroscopy, nerve, muscle, fat

Brief 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.

Interventions

PROCEDURESurgical 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.

Sponsors

Philips Electronics Nederland B.V. acting through Philips CTO organization
CollaboratorINDUSTRY
Philips Healthcare
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differentiation between nerve tissue and its surrounding tissueDay 0Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026