Brief Summary
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.
Brief Title
Coblator Wand Comparative Analysis
Detailed Description
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
914-705-3215
Central Contact Email
hannah.collins@einsteinmed.edu
Central Contact Role
Contact
Central Contact Email
sahsanuddi@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
TONSILLECTOMY
ADENOIDECTOMY
Eligibility Criteria
Inclusion Criteria:
* Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
* Parental consent and child assent (when applicable)
Exclusion Criteria:
* Pregnancy
* Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
* Parental consent and child assent (when applicable)
Exclusion Criteria:
* Pregnancy
Inclusion Criteria
Inclusion Criteria:
* Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
* Parental consent and child assent (when applicable)
* Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
* Parental consent and child assent (when applicable)
Gender
All
Gender Based
false
Keywords
Coblator wand
Product performance
Usability
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
18 Years
Minimum Age
1 Year
NCT Id
NCT07635719
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2025-16898
Overall Status
Not yet recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Comparative Analysis of Efficiency, Technical Performance, and Environmental Cost Between Reprocessed and New Coblator Wands in Intracapsular Tonsillectomies and Adenoidectomies
Primary Outcomes
Outcome Description
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.
Outcome Measure
Surgeon Comfort
Outcome Time Frame
Following the procedure, up to 4 hours
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
18
Minimum Age Number (converted to Years and rounded down)
1
Investigators
Investigator Type
Principal Investigator
Investigator Name
John Bent
Investigator Email
jbent@montefiore.org
Investigator Phone
917-439-5376
Investigator Department
Otorhinolaryngology - Head & Neck Surgery
Investigator Sponsor Organization
Montefiore
Study Department
Otorhinolaryngology - Head & Neck Surgery
Study Division
Non Oncology