Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels.
Kyle J Weld, Stephen Dryer, Greg Hruby...
https://pubmed.ncbi.nlm.nih.gov/16698349/Actively Recruiting
Led by Montefiore Medical Center · Updated on 2026-07-31
30
Participants Needed
1
Research Sites
N/A
Total Duration
This research investigates the use of new versus reprocessed coblator wands during tonsillectomy and adenoidectomy surgeries in children. It aims to compare their efficiency, technical performance, and environmental impact, addressing the existing uncertainty about the reliability of reprocessed surgical tools. The study is randomized and double-blinded, involving pediatric patients undergoing these common surgical procedures. Participants will be randomly assigned to receive either new coblator ablation wands or reprocessed coblator wands that have been refurbished and sterilized. The study focuses on technical performance, including surgeon comfort following the procedure up to 4 hours. The evaluation also considers environmental and hospital cost aspects related to reprocessed versus new surgical tools. During the study, surgeons will assess their comfort with the coblator wands used in surgery. The research team will monitor and compare the performance and technical issues between the two wand types. The entire participation period occurs around the surgical procedure, with outcome measures collected shortly after surgery to inform on tool effectiveness and usability.
CONDITIONS
Coblator Wand Comparative Analysis
H
Hannah Collins
S
Salma Ahsanuddin, MD
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Montefiore Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | New Coblator Wand | Reprocessed Coblator Wand |
|---|---|---|
| Device description | A sterile, single-use coblator ablation wand from Arthrocare, used for soft tissue removal during pediatric tonsillectomy/adenoidectomy. | A previously used coblator ablation wand from Medline, sterilized and repackaged for reuse in pediatric tonsillectomy/adenoidectomy. |
| Role in trial | Used as one randomized device arm to compare ablation performance and surgeon comfort. | Used as the second randomized device arm to compare ablation performance and surgeon comfort. |
| Primary clinical use | Device is intended for precise tissue ablation during pediatric tonsillectomy or adenoidectomy. | Device is intended for the same tissue ablation purpose as a single-use wand, but after sterilization for reuse. |
| How device is used | The new wand is removed from sterile packaging and used for tissue ablation during surgery. | The wand is sterilized, repackaged, and used for tissue ablation according to standard surgical procedure. |
| External published evidence | Published comparative studies support that new surgical device wands generally retain optimal mechanical performance during initial use, with no prior effects of sterilization or wear. | Published evidence shows that reprocessed surgical device wands may exhibit changes in mechanical performance, sharpness, or reliability after sterilization, depending on device type and reprocessing procedure. |
| Important limitations | Performance is only assessed for initial use and may not be directly comparable to devices reused or subjected to reprocessing; cost and environmental impact are not evaluated in this trial. | Performance after reprocessing can vary based on sterilization methods, device materials, and number of reuse cycles; specific safety risks related to reprocessing are not fully evaluated in this trial. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 pre-surgery visit
Duration - Day of surgery
Participants receive either new or reprocessed coblator wands during tonsillectomy or adenoidectomy surgery.
Surgery day visit
Duration - Up to 4 hours post-surgery
Surgeon comfort and technical performance are assessed up to 4 hours after surgery.
1 post-surgery assessment
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Lead Sponsor