Impedance Spectroscopy in Esophageal Cancer
January 13, 2023 updated by: Sana Klinikum Offenbach
Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue
Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Early stages of esophageal cancers can be treated by endoscopic resection whereas advanced neoplasia might lead to an Operation of the esophagus. Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory tissue and cancer can be sensed by electrical bioimpedance technique.
The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.
Study Overview
Detailed Description
Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners.
The early detection is essential to determine the following treatment.
Early stages of esophageal cancers can be treated by endoscopic resection (ER) whereas advanced neoplasia might lead to esophagectomy.
Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies.
The electrical properties in inflammatory tissue and dysplasia can be sensed by electrical bioimpedance technique.
The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
-
Offenbach, Hessen, Germany, 63609
- Sana Clinic Offenbach
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Known esophageal cancer and planned for endoscopic resection
Exclusion Criteria:
- Missing consent / agreement
- Patient in bad condition for endoscopy or endoscopic resection
- Patients with coagulopathy or anticoagulative medication which is a contraindication for endoscopy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Impedance
every resected tissue will measured by an impedance probe
|
After endoscopic resection of early esophageal cancer, the tissue will be measured by an impedance probe between 10Hz-1000000Hz, 20mV.
8 gold electrodes have been integrated to the probe.
The impedance will be measured in different ways between the elctrodes.
There will be 10 measurements in total for each specimen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
impedance
Time Frame: 10 min
|
value of 17 different frequencies in ohm
|
10 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
differences in impedance
Time Frame: 10 min
|
Differences in electrical impedance properties between different stages of early esophageal cancer.
|
10 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mate Knabe, MD, Sana Klinikum Offenbach
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2019
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
February 15, 2020
Study Registration Dates
First Submitted
August 4, 2019
First Submitted That Met QC Criteria
August 4, 2019
First Posted (Actual)
August 6, 2019
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Barrett08/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
6 month
IPD Sharing Access Criteria
Data access request will be discussed by an internal board .
Requestors will be required to sign a Data Access Agreement.
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.