Coblator Wand Comparative Analysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMontefiore Medical Center
About this trial
This study will address the gap in coblator wands by comparing the performance of reprocessed coblator wands with new wands in terms of efficiency and technical issues. As part of the evaluation, the investigator team will conduct the technical performance of the life cycle assessment of reprocessed versus new coblation wands based on the methodology described in the literature (see References) in studies of laryngoscopes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
Parental consent and child assent (when applicable)
Disqualifiers
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
New Coblator Ablation Wands
DeviceNew, unused coblator ablation wands from Arthrocare
Reprocessed Medline Coblator Ablation Wands
DeviceReprocessed coblator ablation wands from Medline
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: New Coblator Ablation WandsActive comparator 1 intervention
Group B: Reprocessed Coblator Ablation WandsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Surgeon Comfort
The primary outcome for this study is surgeon comfort in terms of using the new or reprocessed coblator wand again based on data collected from the post-procedure surveys. Surgeon comfort will be assessed as a dichotomous (yes/no) measure following the procedure. The number of instances for which the surgeon is comfortable using the new or reprocessed coblator wand will be summarized by study arm using descriptive statistics.
Time frame
Following the procedure, up to 4 hoursSponsors and contacts
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Source ClinicalTrials.gov