NCT02108340

Brief Summary

This study will evaluate the use of microwave radiometry in a population of patients diagnosed with acute appendicitis and treated with appendectomy. The main purpose of the study is to report the results of microwave radiometry as a diagnostic tool in acute appendicitis and compare those results with the commonly used ultrasonography.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

3.8 years

First QC Date

April 2, 2014

Last Update Submit

February 11, 2017

Conditions

Appendicitis

Keywords

AppendicitisDiagnosisMicrowave radiometryUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Appendix Temperature

    Microwave radiometry will assess the temperature of the appendix for the patients diagnosed with appendicitis before they undergo surgical removal of the appendix.

    Baseline

Study Arms (1)

Microwave radiometry

EXPERIMENTAL

Patients diagnosed with acute appendicitis will undergo a measurement of the temperature of the appendix with the use of microwave radiometry in a room temperature of 20 -24 degrees celsius.

Procedure: Microwave radiometry

Interventions

Microwave radiometryPROCEDURE

Microwave radiometry of the right lower quadrant in a room temperature of 20-24 degrees celsius, in order to record changes in the temperature of the inflamed appendix.

Microwave radiometry

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of appendicitis
  • Surgical removal of appendix
  • Pathological confirmation of appendicitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hippocration General hospital

Athens, Attica, 115 27, Greece

RECRUITING

Related Publications (4)

  • Toutouzas K, Grassos C, Drakopoulou M, Synetos A, Tsiamis E, Aggeli C, Stathogiannis K, Klettas D, Kavantzas N, Agrogiannis G, Patsouris E, Klonaris C, Liasis N, Tousoulis D, Siores E, Stefanadis C. First in vivo application of microwave radiometry in human carotids: a new noninvasive method for detection of local inflammatory activation. J Am Coll Cardiol. 2012 May 1;59(18):1645-53. doi: 10.1016/j.jacc.2012.01.033.

    PMID: 22538335BACKGROUND

  • Arunachalam K, Maccarini PF, De Luca V, Bardati F, Snow BW, Stauffer PR. Modeling the detectability of vesicoureteral reflux using microwave radiometry. Phys Med Biol. 2010 Sep 21;55(18):5417-35. doi: 10.1088/0031-9155/55/18/010. Epub 2010 Aug 25.

    PMID: 20736499BACKGROUND

  • Toutouzas K, Grassos H, Synetos A, Drakopoulou M, Tsiamis E, Moldovan C, Agrogiannis G, Patsouris E, Siores E, Stefanadis C. A new non-invasive method for detection of local inflammation in atherosclerotic plaques: experimental application of microwave radiometry. Atherosclerosis. 2011 Mar;215(1):82-9. doi: 10.1016/j.atherosclerosis.2010.12.019. Epub 2010 Dec 23. No abstract available.

    PMID: 21256490BACKGROUND

  • Hassan AM, El-Shenawee M. Review of electromagnetic techniques for breast cancer detection. IEEE Rev Biomed Eng. 2011;4:103-18. doi: 10.1109/RBME.2011.2169780.

    PMID: 22273794BACKGROUND

MeSH Terms

Conditions

AppendicitisDisease

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Konstantinos G. Toutouzas, MD, PhD

    Hippocration General Hospital

    STUDY CHAIR

  • Evagelia Stamouli, MD

    Hippocration General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos G. Toutouzas, MD, PhD

CONTACT

00306970801370tousur@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 9, 2014

Study Start

September 1, 2013

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

GR(1)