CClinicalTrials.gg
CompletedNCT01731379NerveSpectUpdated Nov 3, 2015

Optical Detection of Peripheral Nerve Bundles During Surgery

An observational study in Malignant Lymphoma of Lymph Nodes of Inguinal Region, Malignant Lymphoma of Lymph Nodes of Axillary and Malignant Lymphoma of Lymph Nodes of the Cervix, sponsored by Philips Healthcare. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-03.

Sponsored by Philips Healthcare · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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

Keywords

  • spectroscopy
  • nerve
  • muscle
  • fat
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 35 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Philips Healthcare is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Eligible patients are patients of the Netherlands Cancer Institute (NKI-AvL), who are scheduled for an elective inguinal, axillary or cervical lymph node dissection, or parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

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

Exclusion Criteria:

  • Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
35 participants (actual)

Groups and cohorts

  • Surgical resections

    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

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.

    Also known as: lymph node dissection, resection of parotid gland, rectal surgery, soft tumor resection

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0

07

Study locations

1 site
  • Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis
    Amsterdam, Noord-Holland 1066 CX, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01731379
Lead sponsor
Philips Healthcare
Collaborators
Philips Electronics Nederland B.V. acting through Philips CTO organization
Responsible party
Sponsor
First posted
Nov 21, 2012
Start date
Dec 2012
Primary completion
Jan 2014
Completion
Oct 2015
Last update
Nov 3, 2015

Study contacts

Theo Ruers, MD
principal investigator · Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion