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

Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
RPCEC
Registry ID
RPCEC00000129
Enrollment
114
Registered
2012-05-25
Start date
2012-01-03
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Adenoiditis

Interventions

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 e

Sponsors

Center for Aplication and Development of Nuclear Technologies (CEADEN)
Lead Sponsor
Centro Habana Pediatric Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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).

Countries

Cuba

Contacts

Public ContactAlain Riquelme Rodriguez

Policlinic "Rampa"

riquelme@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026