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Optical detection of peripheral nerve bundles during surgery.


- candidate number14054
- NTR NumberNTR3735
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-dec-2012
- Secondary IDsNL40893.031.12 CCMO
- Public TitleOptical detection of peripheral nerve bundles during surgery.
- Scientific TitleIn vivo identification of peripheral nerve bundles during surgery using optical spectroscopy techniques: A pilot study.
- ACRONYM
- hypothesisPrimary 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 during surgery will be evaluated.
- Healt Condition(s) or Problem(s) studiedLymph node dissection, Parotidectomy, Rectal resection for rectal carcinoma, Soft tissue tumour resection
- Inclusion criteria1. 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;
2. Patients that have provided a signed informed consent;
3. Patients ≥ 18 years old.
- Exclusion criteriaPatients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-dec-2012
- planned closingdate17-aug-2013
- Target number of participants22
- InterventionsN/A
- Primary outcomeThe ability of optical spectroscopy to differentiate between nerve tissue and surrounding tissue.
- Secondary outcomePossible improvements of the measurement hardware and evaluation of the handling during surgery.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES N. Langhout
- CONTACT for SCIENTIFIC QUERIESProf. Dr. T.J.M. Ruers
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Philips Research Eindhoven
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD4-dec-2012 - 16-dec-2012


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