Sleep Apnea, ObstructiveNCT02312947
Coblation Versus Cold Adenoidectomy -Safety and Efficiency
A study testing coblation (COBLATION II surgery system ,CE8001-01) and cold dissection adenoidectomy in people with Sleep Apnea, Obstructive, run by Hillel Yaffe Medical Center.
Trial summary
Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient. Read more about this study
- Who is it for?
- Ages 12 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- coblation (COBLATION II surgery system ,CE8001-01) and cold dissection adenoidectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with obstructive symptoms
- the children must perform nasopharyngoscopy with clear evidence of obstructive symptoms ( video or polysomnography more than 5 RDI)
Who cannot join
- without any recent upper respiratory tract infection or clinical suspicious of adenoiditis.
- tonsillectomy
- Non randomalization, not blinded
About this study
Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.
Read the detailed description
Obstructive sleep apnea(osa) in children is a very bother and frequent problem with clinical and behavioral impacts. The hypertrophied adenoid tissue obstructs the air way in the nasopharynx that initiates the common symptoms. The treatment from that concerning problems is in the operation rooms by diversity surgical methods, the very older one is the cold dissection adenoidectomy.
Recently many surgeons use the coblation system as a preferred method for adenoidectomy. This method was proof as a safe and efficient especially referring to the bleeding and the dehydration risk .
Many children that operated by the cold dissection forced to perform another one or two operations presumably due to the adenoid tissue that did not removed completely from the first operation .
our hypothesis is that the coblation systemis a safe and eficient method for adenoidectomy.
The aims of this project is to verify if our theory is corect by blinded comparision between two methods.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- coblation (COBLATION II surgery system ,CE8001-01), cold dissection adenoidectomy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coblation (COBLATION II surgery system ,CE8001-01)Device
Also called COBLATION II surgery system ,CE8001-01
comparison of two methods of operation : coblation and cold dissection
cold dissection adenoidectomyDevice
Also called currete adenoidectomy
comparison of two methods of operation : coblation and cold dissectionby currete
| Study group | Role | What they receive |
|---|---|---|
| coblation | Active comparator | coblation adenoidectomy Receives: Device: coblation (COBLATION II surgery system ,CE8001-01) |
| cold dissection | Active comparator | cold dissection adenoidectomy Receives: Device: cold dissection adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety (bleeding , dehydration or any other complications)
measure the event of bleeding , dehydration or any other complications
Measured: percent of bleeding and dehydration
Secondary outcomes (1)
efficacy (pain post operation by scales evaluation)
pain post operation by scales evaluation and determination whether adenoid tissue left behind after each methods of operation
Measured: pain and examination for residual adenoid tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312947
- Sponsor's protocol ID
- 0047-14-HYMC
- Status last verified
- Dec 2014
- First submitted
- 6 Dec 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coblation Versus Cold Adenoidectomy -Safety and Efficiency
- ClinicalTrials.gov ID
- NCT02312947
- Acronym / sponsor ID
- 0047-14-HYMC
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.
Detailed description
Obstructive sleep apnea(osa) in children is a very bother and frequent problem with clinical and behavioral impacts. The hypertrophied adenoid tissue obstructs the air way in the nasopharynx that initiates the common symptoms. The treatment from that concerning problems is in the operation rooms by diversity surgical methods, the very older one is the cold dissection adenoidectomy.
Recently many surgeons use the coblation system as a preferred method for adenoidectomy. This method was proof as a safe and efficient especially referring to the bleeding and the dehydration risk .
Many children that operated by the cold dissection forced to perform another one or two operations presumably due to the adenoid tissue that did not removed completely from the first operation .
our hypothesis is that the coblation systemis a safe and eficient method for adenoidectomy.
The aims of this project is to verify if our theory is corect by blinded comparision between two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coblation | Active comparator | Device: coblation (COBLATION II surgery system ,CE8001-01)coblation adenoidectomy |
| cold dissection | Active comparator | Device: cold dissection adenoidectomycold dissection adenoidectomy |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with obstructive symptoms
- the children must perform nasopharyngoscopy with clear evidence of obstructive symptoms ( video or polysomnography more than 5 RDI)
Key exclusion criteria (3 listed)
- without any recent upper respiratory tract infection or clinical suspicious of adenoiditis.
- tonsillectomy
- Non randomalization, not blinded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coblation (COBLATION II surgery system ,CE8001-01)Also: COBLATION II surgery system ,CE8001-01comparison of two methods of operation : coblation and cold dissection | Device | coblation |
| cold dissection adenoidectomyAlso: currete adenoidectomycomparison of two methods of operation : coblation and cold dissectionby currete | Device | cold dissection |
Primary outcome
safety (bleeding , dehydration or any other complications)
Time frame: percent of bleeding and dehydration
measure the event of bleeding , dehydration or any other complications
1 secondary outcome
efficacy (pain post operation by scales evaluation)
Time frame: pain and examination for residual adenoid tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
Related trials for Sleep Apnea, Obstructive
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing coblation (COBLATION II surgery system ,CE8001-01) and cold dissection adenoidectomy in people with Sleep Apnea, Obstructive, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (bleeding , dehydration or any other complications) (time frame: percent of bleeding and dehydration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014; AzTrials last refreshed its copy on 29 Oct 2026.