TonsillectomyNCT07635719
Coblator Wand Comparative Analysis
A study testing New Coblator Ablation Wands and Reprocessed Medline Coblator Ablation Wands in people with Tonsillectomy and Adenoidectomy, run by Montefiore Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Tonsillectomy, Adenoidectomy
- What is being tested?
- New Coblator Ablation Wands and Reprocessed Medline Coblator Ablation Wands
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
- Parental consent and child assent (when applicable)
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Salma Ahsanuddin, MD contact
United States1 site, 1 recruiting
- Recruiting
Children's Hosptial at Montefiore
The Bronx, New York, 10467
Hannah Collins, 914-705-3215, hannah.collins@einsteinmed.edu
Salma Ahsanuddin, MD, sahsanuddi@montefiore.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Tonsillectomy, Adenoidectomy
- Being tested
- New Coblator Ablation Wands, Reprocessed Medline Coblator Ablation Wands
- Keywords
- Coblator wand, Product performance, Usability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Coblator Ablation WandsDevice
Also called Coblator II EVac 70 Plasma Wand
New, unused coblator ablation wands from Arthrocare
Reprocessed Medline Coblator Ablation WandsDevice
Also called ReNewal Reprocessed Arthrocare Ablation Wand
Reprocessed coblator ablation wands from Medline
| Study group | Role | What they receive |
|---|---|---|
| New Coblator Ablation Wands | Active comparator | Not described Receives: Device: New Coblator Ablation Wands |
| Reprocessed Coblator Ablation Wands | Active comparator | Not described Receives: Device: Reprocessed Medline Coblator Ablation Wands |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following the procedure, up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Bent, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635719
- Sponsor's protocol ID
- 2025-16898
- Other IDs
- 2025
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28166171Ledonio 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.
PubMed 24683649Mues 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.
PubMed 21036630Weld 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.
PubMed 16698349Jin 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.
PubMed 23924492
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Efficiency, Technical Performance, and Environmental Cost Between Reprocessed and New Coblator Wands in Intracapsular Tonsillectomies and Adenoidectomies
- ClinicalTrials.gov ID
- NCT07635719
- Acronym / sponsor ID
- 2025-16898
- Conditions
- Tonsillectomy, Adenoidectomy
- Keywords
- Coblator wand, Product performance, Usability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Coblator Ablation Wands | Active comparator | Device: New Coblator Ablation Wands |
| Reprocessed Coblator Ablation Wands | Active comparator | Device: Reprocessed Medline Coblator Ablation Wands |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
- Parental consent and child assent (when applicable)
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Coblator Ablation WandsAlso: Coblator II EVac 70 Plasma WandNew, unused coblator ablation wands from Arthrocare | Device | New Coblator Ablation Wands |
| Reprocessed Medline Coblator Ablation WandsAlso: ReNewal Reprocessed Arthrocare Ablation WandReprocessed coblator ablation wands from Medline | Device | Reprocessed Coblator Ablation Wands |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 28166171Myers 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.
- Background: PubMed 24683649Ledonio 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.
- Background: PubMed 21036630Mues 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.
- Background: PubMed 16698349Weld 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.
- Background: PubMed 23924492Jin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salma Ahsanuddin, MD contact
John Bent, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Coblator Ablation Wands and Reprocessed Medline Coblator Ablation Wands in people with Tonsillectomy and Adenoidectomy, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Collins (914-705-3215, hannah.collins@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Comfort (time frame: Following the procedure, up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07635719, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.