Optical Detection of Peripheral Nerve Bundles During Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Surgical resection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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lymph node dissection resection of parotid gland rectal surgery soft tumor resection

Eligibility Criteria

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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