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:
Issuing authority of the secondary identifying numbers:
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)
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
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:
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
Date of first enrollment:
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:
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.
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.
Study design Section to complete information about the characteristics of the study design.
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
Postal Address:
Calle 17 esq. a J. Plaza de la Revolucion
Telephone:
537-832-7019, 537-882-0616
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.
Affiliation:
Centro Habana Pediatric Hospital
Postal Address:
Benjumeda esq. a Callejon Xifres. Centro Habana
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).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
