AppendicitisNCT02108340
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis
A study testing Microwave radiometry in people with Appendicitis, run by Hippocration General Hospital at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis
- What is being tested?
- Microwave radiometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of appendicitis
- Surgical removal of appendix
- Pathological confirmation of appendicitis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hippocration General hospital
Athens, Attica, 115 27
Konstantinos G. Toutouzas, MD, PhD
Evagelia Stamouli, MD
About this study
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.
Read the detailed description
Patients diagnosed with acute appendicitis from the emergency department of Hippocration General Hospital and treated with appendectomy will be evaluated with microwave radiometry for changes in the temperature of the appendix before its removal.
Subsequently, the results of microwave radiometry for the patients confirmed by the histopathology report to have acute inflammation of the appendix, will be compared with those of the ultrasonography used for the diagnosis of acute appendicitis.
- Conditions
- Appendicitis
- Being tested
- Microwave radiometry
- Keywords
- Appendicitis, Diagnosis, Microwave radiometry, Ultrasonography
- Medical subject headings
- Appendicitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave radiometryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Microwave radiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Toutouzas, Hippocration General Hospital
- Investigators
- Konstantinos G. Toutouzas, MD, PhD, Study chair, Hippocration General HospitalEvagelia Stamouli, MD, Principal investigator, Hippocration General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108340
- Sponsor's protocol ID
- ΕΣ 45/19-9-2013
- Status last verified
- Feb 2017
- First submitted
- 2 Apr 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22538335Arunachalam 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.
PubMed 20736499Toutouzas 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.
PubMed 21256490Hassan 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.
PubMed 22273794
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis
- ClinicalTrials.gov ID
- NCT02108340
- Acronym / sponsor ID
- ΕΣ 45/19-9-2013
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Diagnosis, Microwave radiometry, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients diagnosed with acute appendicitis from the emergency department of Hippocration General Hospital and treated with appendectomy will be evaluated with microwave radiometry for changes in the temperature of the appendix before its removal.
Subsequently, the results of microwave radiometry for the patients confirmed by the histopathology report to have acute inflammation of the appendix, will be compared with those of the ultrasonography used for the diagnosis of acute appendicitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave radiometry | Experimental | Procedure: Microwave radiometryPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of appendicitis
- Surgical removal of appendix
- Pathological confirmation of appendicitis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave radiometryMicrowave 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. | Procedure or surgery | Microwave radiometry |
Primary outcome
Appendix Temperature
Time frame: Baseline
Microwave radiometry will assess the temperature of the appendix for the patients diagnosed with appendicitis before they undergo surgical removal of the appendix.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Background: PubMed 22538335Toutouzas 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.
- Background: PubMed 20736499Arunachalam 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.
- Background: PubMed 21256490Toutouzas 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.
- Background: PubMed 22273794Hassan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos G. Toutouzas, MD, PhD study chair
Hippocration General Hospital
Evagelia Stamouli, MD principal investigator
Hippocration General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave radiometry in people with Appendicitis, run by Hippocration General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos G. Toutouzas, MD, PhD (00306970801370, tousur@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendix Temperature (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108340, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.