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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

Tracking Information
First Submitted Date  ICMJE August 4, 2019
First Posted Date  ICMJE August 6, 2019
Last Update Posted Date December 9, 2019
Actual Study Start Date  ICMJE October 9, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2019)
impedance [ Time Frame: 10 min ]
value of 17 different frequencies in ohm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2019)
differences in impedance [ Time Frame: 10 min ]
Differences in electrical impedance properties between different stages of early esophageal cancer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impedance Spectroscopy in Esophageal Cancer
Official Title  ICMJE Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cancer of Esophagus
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Impedance
every resected tissue will measured by an impedance probe
Intervention: Device: impedance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 3, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mate Knabe, MD 00496984057249 MATE.KNABE@GOOGLEMAIL.COM
Contact: Sandra Blößer 004917672139592 sandra.bloesser@gmx.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04046601
Other Study ID Numbers  ICMJE Barrett08/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party Sana Klinikum Offenbach
Study Sponsor  ICMJE Sana Klinikum Offenbach
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mate Knabe, MD Sana Klinikum Offenbach
PRS Account Sana Klinikum Offenbach
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP