An interventional study of New Coblator Ablation Wands and Reprocessed Medline Coblator Ablation Wands in Tonsillectomy and Adenoidectomy, sponsored by Montefiore Medical Center. Recruiting at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Other
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.
Reprocessed operating room tools offer surgeons an opportunity to use equipment that have been inferenced to incur lower hospital and environmental costs. Tools that are "disposable" are collected by reprocessing companies that then refurbish and sterilize the instrument and sell it back to the hospital at a reduced cost. Advocates argue that they may serve as a means of controlling increasing healthcare costs and further, because few if any new raw materials are needed for the reprocessing, environmental costs are also hypothesized to be reduced. However, the use of reprocessed tools has demonstrated variable results in clinical performance across different surgical domains. Comparable performance of reprocessed orthopedic drill bits to new ones in terms of force, heat, and usability has been demonstrated (see References). It has been shown that blinded surgeons could not distinguish between new and reprocessed arthroscopic shavers and found equivalent sharpness on engineering tests. In contrast, it has been found that reprocessed laparoscopic trocars had more imperfections and higher leak rates (see References) reported more abnormalities in reprocessed harmonic scalpels with poorer tissue handling outcomes. There remains a lack of consensus about the reliability of reprocessed surgical tools, including coblator wands.
Exclusion Criteria:
Device: New Coblator Ablation Wands
Device: Reprocessed Medline Coblator Ablation Wands
New, unused coblator ablation wands from Arthrocare
Also known as: Coblator II EVac 70 Plasma Wand
Reprocessed coblator ablation wands from Medline
Also known as: ReNewal Reprocessed Arthrocare Ablation Wand
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 hours
Plan to share: No
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Montefiore Medical Center