NCT01641276

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 14, 2015

Status Verified

June 1, 2015

Enrollment Period

3.2 years

First QC Date

July 12, 2012

Last Update Submit

September 10, 2015

Conditions

Keywords

biofeedback response

Outcome Measures

Primary Outcomes (1)

  • 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

    within 10 min of exposure

Secondary Outcomes (1)

  • Characterization of differences biofeedback response in hepatitis B carriers with and without hepatocellular carcinoma

    within 10 minutes of exposure

Study Arms (2)

hepatitis

EXPERIMENTAL

hepatitis B carriers patients

Device: Low intensity amplitude-moduled electromagnetic fields

hepatocellular carcinoma patients

EXPERIMENTAL

hepatites B carriers patients with associated hepatocellular carcinoma

Device: Low intensity amplitude-moduled electromagnetic fields

Interventions

Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time.

Also known as: TheraBionic, OncoBionic P1
hepatitishepatocellular carcinoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hepatitis B carriers patients
  • hepatitis B carriers patients with hepatocellular cancer patients

You may not qualify if:

  • other tumor types
  • other hepatitis types

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sírio Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Related Links

MeSH Terms

Conditions

HepatitisCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Frederico P Costa, MD

    Hospital Sirio-Libanes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 16, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-06

Locations