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Trial record 4 of 12 for:    electrical impedance spectroscopy

Impedance Spectroscopy in Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046601
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Sana Klinikum Offenbach

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer of Esophagus Device: impedance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Observation group: patient who are planned for endoscopic resection because of known esophageal cancer. Immediately after retrieval the resected specimens will be investigated for their electrical impedance properties. The results of the impedance measurement are compared to the histological results.
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Diagnostic
Official Title: Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Impedance
every resected tissue will measured by an impedance probe
Device: impedance
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.




Primary Outcome Measures :
  1. impedance [ Time Frame: 10 min ]
    value of 17 different frequencies in ohm


Secondary Outcome Measures :
  1. differences in impedance [ Time Frame: 10 min ]
    Differences in electrical impedance properties between different stages of early esophageal cancer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Known esophageal cancer and planned for endoscopic resection

Exclusion Criteria:

  1. Missing consent / agreement
  2. Patient in bad condition for endoscopy or endoscopic resection
  3. Patients with coagulopathy or anticoagulative medication which is a contraindication for endoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046601


Contacts
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Contact: Mate Knabe, MD 00496984057249 MATE.KNABE@GOOGLEMAIL.COM
Contact: Sandra Blößer 004917672139592 sandra.bloesser@gmx.de

Locations
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Germany
Sana Clinic Offenbach Recruiting
Offenbach, Hessen, Germany, 63609
Contact: Mate Knabe, MD    017632256069    mate.knabe@googlemail.com   
Contact: Sandra Blößer       sandra.bloesser@gmx.de   
Principal Investigator: Mate Knabe, MD         
Sponsors and Collaborators
Sana Klinikum Offenbach
Investigators
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Principal Investigator: Mate Knabe, MD Sana Klinikum Offenbach
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Responsible Party: Sana Klinikum Offenbach
ClinicalTrials.gov Identifier: NCT04046601    
Other Study ID Numbers: Barrett08/2019
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: 6 month
Access Criteria: Data access request will be discussed by an internal board . Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sana Klinikum Offenbach:
impedance, Barrett´s cancer, early detection of cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases