Revisions for Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis - Phase III | Registro Público Cubano de Ensayos Clínicos

24 November 2015 - 2:48pm by CEADEN	24 November 2015 - 2:48pm by CEADEN
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Changes to Secondary sponsor
-	Policlinic "Rampa"	+	Centro Habana Pediatric Hospital

Revision of 24 November 2015 - 2:48pm:

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

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

Country:

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

Country:

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

Country:

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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Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis - Phase III

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