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Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis - Phase III
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Revisiones
Comparando dos revisiones:
24 Noviembre 2015 - 2:48pm
por CEADEN
24 Noviembre 2015 - 2:48pm
por CEADEN
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Cambios a
Secondary sponsor
-
Policlinic "Rampa"
+
Centro Habana Pediatric Hospital
Revisión actual:
Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis - Phase III
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center for Aplication and Development of Nuclear Technologies (CEADEN)
Secondary sponsor:
Centro Habana Pediatric Hospital
Source(s) of monetary or material support:
Center for Aplication and Development of Nuclear Technologies (CEADEN)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of the Quality of Drugs(CECMED)
Authorization date :
09/11/2011
Reference number:
006012
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Amalia Flor Nieves Alvarez, MD. 1st Degree specialist in Otorhinolaryngology
Last name:
Not entered
Affiliation:
Not entered
Postal address:
Not entered
City:
Not entered
País:
Not entered
Zip Code:
Not entered
Email address:
email@not.entered
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Research ethics committees:
Centro Habana Pedriatric, February 24th, 2011
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
03/01/2012
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Chronic Adenoiditis
Intervention(s):
Podal Reflex Laserpuncture, with a semiconductor laser AsGa with 780 mm wavelength (infrared), 40mW power output, in a continuos work regime. The dosage to use is: energy density (DE) 35 J/cm2 or an energy dosage of 2.4 J on each application with 3 application on the reflex zone of each foot corresponding to the nose holes, resulting in a density of total energy per sesion of 210 J/cm2 or an energy dosage de 14.4 J in 6 application in a treatment cycle consisting in a sesion each day Monday through Friday, to complete 15 sesions.
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Clinical response (Interrogation and Physical exam). Measurement Time: 15 days and 3 months after finishing the treatmnet. - Interrogation. Presence or absence of mucopurulent secretion on the pharynge wall. Infections of aerial ways and snoring at nigth. - Physical Exam. Presence of Cronic Adenoiditis. It will include: 1. Nasopharyngeal tac in children 4 years old or younger. 2. Back rynoscopy using larynge mirror or nasofibroscopy in children older than 4 years old. 3. Cavum X Rays for children who don't cooperate on the tests 1 and 2
Key secondary outcomes:
Need of surgery (Yes, No). Measurement Time: 16 days and 3 month after finishing the treatment. - Adverse Event (AE). Measurement Time: 16 days and 3 month after finishing the treatment. Type of AE (name of the adverse event) Intensity of the AE (Mild, moderate, severe) Severity of the AE (Grave/Serious, Not Grave/Not serious) Causal Relationship of the AE (Remote cause, Possible Cause, Probable cause or Very Probable cause/sure) Treatment indicated (treatment received by each patient for the AE occurred).
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
1 years
Maximum age:
18 years
Inclusion criteria:
1. Patients male and female, 1 to 4 years old. 2. Patients showing at least 3 clinical symptoms of chronic adenoiditis sush as: snoring, mucus secretion on the pharinge wall and infection of the aerial ways. 3. Written approval of informed consent by the legal representative of the patient to participate in the trial 4. Presence of chronic adenoiditis confirmed by means of nosopharinge tact, back rinoscopy, nasofibroscopy or Xrays of the cavum.
Exclusion criteria:
1. Small babies feed by the mother. 2. Hemophiliac patients. 3. Patients with malignant tumors. 4. Hipertrofic adenoiditis asociated to a complete obstruction of the breathing ways. 5. Medium otitis. 6. Patients with fever.
Type of population:
Children
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Observational
Purpose:
Treatment
Allocation:
N/A: single arm study
Masking:
Open
Control group:
Uncontrolled
Study design:
Single group
Phase:
3
Target sample size:
114
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Alain
Last Name:
Riquelme Rodriguez
Affiliation:
Policlinic "Rampa"
Postal Address:
Calle 17 esq. a J. Plaza de la Revolucion
City:
La Habana
País:
Cuba
Zip Code:
11400
Telephone:
537-832-7019, 537-882-0616
Email :
riquelme@infomed.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Amalia
Middle Name:
Flor
Last Name:
Nieves Alvarez
Affiliation:
Centro Habana Pediatric Hospital
Postal Address:
Benjumeda esq. a Callejon Xifres. Centro Habana
City:
La Habana
País:
Cuba
Zip Code:
10200
Telephone:
537-835-5222
Email :
amalian@infomed.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000129
Date of Registration in Primary Registry:
2012-05-25
Record Verification Date:
2015/11/24
Next update date:
2016/11/24
Link to the spanish version:
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