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Optical Detection of Peripheral Nerve Bundles During Surgery (NerveSpect)

This study is currently recruiting participants.
Verified December 2012 by Philips Healthcare
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01731379
First received: November 16, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
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
 Procedure: Surgical resection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Differentiation between nerve tissue and its surrounding tissue [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations


Estimated Enrollment: 22
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731379

Contacts
Contact: Theo Ruers, MD +31 020 5152565 t.ruers@nki.nl
Contact: Koert Kuhlmann, MD :+31(0)20 5126990 k.kuhlmann@nki.nl

Locations
Netherlands
Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Contact: Jarich Spliethoff, MSc     +31 020 5127491     j.spliethoff@nki.nl    
Contact: Niels Langhout, MSc     +31 020 5122316     n.langhout@nki.nl    
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Theo Ruers, MD Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01731379     History of Changes
Other Study ID Numbers: NL 40893.031.12
Study First Received: November 16, 2012
Last Updated: December 10, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Philips Healthcare:
spectroscopy
nerve
muscle
fat

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Rectal Neoplasms
Colorectal Neoplasms
Lymphoma
Soft Tissue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013