NCT07635719

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

TonsillectomyAdenoidectomy

Keywords

Coblator wandProduct performanceUsability

Outcome Measures

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.

    Following the procedure, up to 4 hours

Study Arms (2)

New Coblator Ablation Wands

ACTIVE COMPARATOR
Device: New Coblator Ablation Wands

Reprocessed Coblator Ablation Wands

ACTIVE COMPARATOR
Device: Reprocessed Medline Coblator Ablation Wands

Interventions

New Coblator Ablation WandsDEVICE

New, unused coblator ablation wands from Arthrocare

Also known as: Coblator II EVac 70 Plasma Wand
New Coblator Ablation Wands
Reprocessed Medline Coblator Ablation WandsDEVICE

Reprocessed coblator ablation wands from Medline

Also known as: ReNewal Reprocessed Arthrocare Ablation Wand
Reprocessed Coblator Ablation Wands

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hosptial at Montefiore

The Bronx, New York, 10467, United States

Location

Related Publications (5)

  • 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.

    PMID: 28166171BACKGROUND

  • 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.

    PMID: 24683649BACKGROUND

  • 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.

    PMID: 21036630BACKGROUND

  • 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.

    PMID: 16698349BACKGROUND

  • 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.

    PMID: 23924492BACKGROUND

Study Officials

  • John Bent, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Collins

CONTACT

914-705-3215hannah.collins@einsteinmed.edu

Salma Ahsanuddin, MD

CONTACT

sahsanuddi@montefiore.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)