Optical Detection of Peripheral Nerve Bundles During Surgery (NerveSpect)

Philips

Status: Completed

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

Treatments: Procedure: Surgical resection

Study type: Observational

Funder types: Industry

Identifiers

NCT01731379

NL 40893.031.12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

Surgical resections

Description:

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.

Treatment:

Procedure: Surgical resection