- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731379
Optical Detection of Peripheral Nerve Bundles During Surgery (NerveSpect)
In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Netherlands, 1066 CX
- Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differentiation between nerve tissue and its surrounding tissue
Time Frame: Day 0
|
Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations
|
Day 0
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL 40893.031.12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Lymphoma of Lymph Nodes of Inguinal Region
-
Haukeland University HospitalUniversity of BergenCompletedSecondary Malignant Neoplasm of Lymph Node | Disorder of Upper Gastrointestinal Tract | Pancreatic Nodule | Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph NodesNorway
-
Centre hospitalier de l'Université de Montréal...Centre de Recherche du Centre Hospitalier de l'Université de MontréalCompletedNeoplasm of Mediastinal Lymph NodesCanada
-
Shandong UniversityUnknownMalignancy or Benign of Enlarged Lymph NodesChina
-
Hospital Sao RafaelCompletedHodgkin Disease | Malignant Neoplasm of Breast | Malignant Neoplasm of Colon | Non-Hodgkin Lymphoma, Follicular (Nodular) | Malignant Neoplasm of Bronchus and Lung | Secondary Neoplasm Malignant and Unspecified Lymph Nodes | Malignant Melanoma of the Skin | Malignant Neoplasm of Small IntestineBrazil
-
Ahmed Mohamed AbdelraufCompletedEdema Due to Obstruction of Lymph Vessels or Excision of Lymph NodesEgypt
-
University of Medicine and Pharmacy CraiovaTel-Aviv Sourasky Medical Center; Shengjing Hospital; Institut Paoli-Calmettes; University of Santiago de Compostela and other collaboratorsCompletedPancreatic Cancer | Secondary Malignant Neoplasm of Lymph Node | Benign Neoplasm of Lymph Nodes | Benign Pancreatic TumorsRomania
-
San Antonio Uniformed Services Health Education...Not yet recruitingCryobiopsy of Peripheral Lymph NodesUnited States
-
Cao Pharmaceuticals Inc.The University of Texas Health Science Center at San AntonioUnknownSolid Tumor | Malignant Lymphoma of Extranodal and/or Solid Organ SiteUnited States
-
National Taiwan University HospitalUnknownMetastasis Cervical Lymph Nodes of Unknown Primary CarcinomaTaiwan
-
Fondation Ophtalmologique Adolphe de RothschildRecruitingDescription of Local Modifications of Lymph Nodes or Bundles With the FABIR Sequence in MRIFrance
Clinical Trials on Surgical resection
-
Qazvin University Of Medical SciencesUnknownOral Lichen PlanusIran, Islamic Republic of
-
Zagazig UniversityCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...Technische Universität Dresden; University of Debrecen; Koc University Hospital; Hospital de la Santa creu i Sant Pau - Barcelona and other collaboratorsNot yet recruiting
-
Fudan UniversityShanghai Pulmonary Hospital, Shanghai, China; Zhoupu Hospital, Pudong New Area... and other collaboratorsRecruitingLung Adenocarcinoma | Surgical Procedure, Unspecified | PathologyChina
-
Grupo Espanol de Trabajo en Enfermedad de Crohn...Recruiting
-
University Hospital, ToursRecruiting
-
Toronto Sunnybrook Regional Cancer CentreOntario Clinical Oncology Group (OCOG); Ontario Cancer Research NetworkCompletedNon-Small Cell Lung CancerCanada
-
Fudan UniversityRecruitingLung Adenocarcinoma | Surgical Procedure, Unspecified | PathologyChina
-
Sahlgrenska University Hospital, SwedenCompleted
-
Alexandria UniversityCompletedGastrointestinal Stromal Tumor of DuodenumEgypt