Coblator Wand Comparative Analysis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tonsillectomy; Adenoidectomy
• Intervention / Treatment: Device: New Coblator Ablation Wands; Device: Reprocessed Medline Coblator Ablation Wands

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Collins; Phone Number: 914-705-3215; Email: hannah.collins@einsteinmed.edu
• Study Contact Backup: Name: Salma Ahsanuddin, MD; Email: sahsanuddi@montefiore.org

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10467
      • Children's Hosptial at Montefiore
      • Contact: Hannah Collins; Phone Number: 914-705-3215; Email: hannah.collins@einsteinmed.edu
      • Contact: Salma Ahsanuddin, MD; Email: sahsanuddi@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: New Coblator Ablation Wands	Device: New Coblator Ablation Wands; New, unused coblator ablation wands from Arthrocare; Other Names: Coblator II EVac 70 Plasma Wand
Active Comparator: Reprocessed Coblator Ablation Wands	Device: Reprocessed Medline Coblator Ablation Wands; Reprocessed coblator ablation wands from Medline; Other Names: ReNewal Reprocessed Arthrocare Ablation Wand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Following the procedure, up to 4 hours

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: John Bent, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• Weld KJ, Dryer S, Hruby G, Ames CD, Venkatesh R, Matthews BD, Landman J. Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. Urology. 2006 May;67(5):898-903. doi: 10.1016/j.urology.2005.11.027.
• Mues AC, Haramis G, Casazza C, Okhunov Z, Badani KK, Landman J. Prospective randomized single-blinded in vitro and ex vivo evaluation of new and reprocessed laparoscopic trocars. J Am Coll Surg. 2010 Dec;211(6):738-43. doi: 10.1016/j.jamcollsurg.2010.08.003. Epub 2010 Oct 30.
• Myers R, Kim H, Hsieh AH, O'Toole RV, Sciadini MF. When Should We Change Drill Bits? A Mechanical Comparison of New, Reprocessed, and Damaged Bits. J Orthop Trauma. 2017 May;31(5):281-286. doi: 10.1097/BOT.0000000000000812.
• Ledonio CG, Arendt EA, Adams JE, Matz J, Boers A, Miller K, Lester BR. Reprocessed arthroscopic shavers: evaluation of sharpness and function in a cadaver model. Orthopedics. 2014 Jan;37(1):e1-9. doi: 10.3928/01477447-20131219-09.
• Jin T, Huang W, Jiang K, Xiong JJ, Xue P, Javed MA, Yang XN, Xia Q. Urinary trypsinogen-2 for diagnosing acute pancreatitis: a meta-analysis. Hepatobiliary Pancreat Dis Int. 2013 Aug;12(4):355-62. doi: 10.1016/s1499-3872(13)60056-9.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Usability; Coblator wand; Product performance
• Other Study ID Numbers: 2025-16898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No