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NCT Number: NCT07635719

Coblator Wand Comparative Analysis

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
  • Parental consent and child assent (when applicable)

Exclusion criteria

  • Pregnancy

Treatment and study plan

New Coblator Ablation Wands

Device

New, unused coblator ablation wands from Arthrocare

Other names: Coblator II EVac 70 Plasma Wand

Reprocessed Medline Coblator Ablation Wands

Device

Reprocessed coblator ablation wands from Medline

Other names: ReNewal Reprocessed Arthrocare Ablation Wand

Primary outcomes

  1. Surgeon Comfort

    Time frame: Following the procedure, up to 4 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Collins

CONTACT

[email protected]

914-705-3215

Salma Ahsanuddin, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Comparative Analysis of Efficiency, Technical Performance, and Environmental Cost Between Reprocessed and New Coblator Wands in Intracapsular Tonsillectomies and Adenoidectomies

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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