NCT02312947

Brief Summary

Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Status
unknown

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

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

Same day

First QC Date

December 6, 2014

Last Update Submit

December 8, 2014

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • safety (bleeding , dehydration or any other complications)

    measure the event of bleeding , dehydration or any other complications

    percent of bleeding and dehydration

Secondary Outcomes (1)

  • efficacy (pain post operation by scales evaluation)

    pain and examination for residual adenoid tissue

Study Arms (2)

coblation

ACTIVE COMPARATOR

coblation adenoidectomy

Device: coblation (COBLATION II surgery system ,CE8001-01)

cold dissection

ACTIVE COMPARATOR

cold dissection adenoidectomy

Device: cold dissection adenoidectomy

Interventions

coblation (COBLATION II surgery system ,CE8001-01)DEVICE

comparison of two methods of operation : coblation and cold dissection

Also known as: COBLATION II surgery system ,CE8001-01
coblation
cold dissection adenoidectomyDEVICE

comparison of two methods of operation : coblation and cold dissectionby currete

Also known as: currete adenoidectomy
cold dissection

Eligibility Criteria

Age12 Months - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children with obstructive symptoms
  • the children must perform nasopharyngoscopy with clear evidence of obstructive symptoms ( video or polysomnography more than 5 RDI)

You may not qualify if:

  • without any recent upper respiratory tract infection or clinical suspicious of adenoiditis.
  • tonsillectomy
  • Non randomalization, not blinded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2014

First Posted

December 9, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

December 9, 2014

Record last verified: 2014-12