HepatitisTHBC-HSL2NCT01641276
Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma
A study testing Low intensity amplitude-moduled electromagnetic fields in people with Hepatitis and Hepatocellular Carcinomas, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
The propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis, Hepatocellular Carcinomas
- What is being tested?
- Low intensity amplitude-moduled electromagnetic fields
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hepatitis B carriers patients
- hepatitis B carriers patients with hepatocellular cancer patients
Who cannot join
- other tumor types
- other hepatitis types
Trial locations and contacts
1 site in 1 country.
About this study
The propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.
Read the detailed description
Patients will be exposed by different specific amplitude-modulated frequencies of low intensity electromagnetic fields for 30 min. During the exposure, autonomic response with be recorded in order to identify biofeedback response. Differences in group of frequencies is expected in patients with hepatitis B carries with or without hepatocellular carcinoma.
- Conditions
- Hepatitis, Hepatocellular Carcinomas
- Being tested
- Low intensity amplitude-moduled electromagnetic fields
- Keywords
- biofeedback response
- Medical subject headings
- Hepatitis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity amplitude-moduled electromagnetic fieldsDevice
Also called TheraBionic, OncoBionic P1
Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time.
| Study group | Role | What they receive |
|---|---|---|
| hepatitis | Experimental | hepatitis B carriers patients Receives: Device: Low intensity amplitude-moduled electromagnetic fields |
| hepatocellular carcinoma patients | Experimental | hepatites B carriers patients with associated hepatocellular carcinoma Receives: Device: Low intensity amplitude-moduled electromagnetic fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of different group of specific frequencies of modulation in hepatitis B carriers with and without hepatocellular carcinoma associated with biofeedback response
biofeedback response will be monitored
Measured: within 10 min of exposure
Secondary outcomes (1)
Characterization of differences biofeedback response in hepatitis B carriers with and without hepatocellular carcinoma
Representation of autonomous response during the exposure of specific frequencies of modulation
Measured: within 10 minutes of exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Perego Costa, Hospital Sirio-Libanes
- Investigators
- Frederico P Costa, MD, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641276
- Sponsor's protocol ID
- 02621512.3.0000.5461
- Acronym
- THBC-HSL2
- Status last verified
- Jun 2015
- First submitted
- 12 Jul 2012
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01641276
- Acronym / sponsor ID
- THBC-HSL2 / 02621512.3.0000.5461
- Conditions
- Hepatitis, Hepatocellular Carcinomas
- Keywords
- biofeedback response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Jul 2012 (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.
The propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.
Detailed description
Patients will be exposed by different specific amplitude-modulated frequencies of low intensity electromagnetic fields for 30 min. During the exposure, autonomic response with be recorded in order to identify biofeedback response. Differences in group of frequencies is expected in patients with hepatitis B carries with or without hepatocellular carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatitis | Experimental | Device: Low intensity amplitude-moduled electromagnetic fieldshepatitis B carriers patients |
| hepatocellular carcinoma patients | Experimental | Device: Low intensity amplitude-moduled electromagnetic fieldshepatites B carriers patients with associated hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hepatitis B carriers patients
- hepatitis B carriers patients with hepatocellular cancer patients
Key exclusion criteria (2 listed)
- other tumor types
- other hepatitis types
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 |
|---|---|---|
| Low intensity amplitude-moduled electromagnetic fieldsAlso: TheraBionic, OncoBionic P1Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time. | Device | hepatitis, hepatocellular carcinoma patients |
Primary outcome
Identification of different group of specific frequencies of modulation in hepatitis B carriers with and without hepatocellular carcinoma associated with biofeedback response
Time frame: within 10 min of exposure
biofeedback response will be monitored
1 secondary outcome
Characterization of differences biofeedback response in hepatitis B carriers with and without hepatocellular carcinoma
Time frame: within 10 minutes of exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Results of a phase II study on patients with hepatocellular carcinomaLink provided by the sponsor.
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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.
Frederico P Costa, MD principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity amplitude-moduled electromagnetic fields in people with Hepatitis and Hepatocellular Carcinomas, run by Hospital Sirio-Libanes at 1 site in Brazil.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 14 Sep 2015. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of different group of specific frequencies of modulation in hepatitis B carriers with and without hepatocellular carcinoma associated with biofeedback response (time frame: within 10 min of exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2015.