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BiZact Device for Tonsillectomy

N/A

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tonsil hypertrophy with sleep disordered breathing

Recurrent tonsillitis or pharyngitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

Study Summary

This trial is testing a new device for tonsillectomy to see if it is more effective than the standard device. The new device is associated with less blood loss and shorter surgery time, but has the same rate of post-operative bleeding as other devices.

Who is the study for?

This trial is for children with recurring tonsillitis, throat infections, uneven or enlarged tonsils causing breathing issues during sleep, or persistent tonsil stones. Participants must be able to take ibuprofen. It's not suitable for those with Down's Syndrome, other craniofacial syndromes, a history of previous tonsillectomy, or bleeding disorders like von Willebrand's disease.Check my eligibility

What is being tested?

The study tests the BiZact device against standard care in pediatric tonsillectomies to see if it can reduce surgery time and postoperative complications. A prior study indicated that the BiZact might lead to less blood loss and quicker surgeries without increasing post-surgery bleeding risks.See study design

What are the potential side effects?

While specific side effects are not listed for BiZact itself, common side effects from tonsillectomy procedures include pain after surgery, risk of bleeding especially within two weeks post-operation (postoperative hemorrhage), and potential reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My enlarged tonsils cause me breathing problems when I sleep.

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I frequently get tonsillitis or sore throat.

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My tonsils are uneven or I have a tonsil tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Emergency room visits

Intra-operative blood loss

Secondary outcome measures

Operating time

Pain level

Pain medication documentation

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BiZactExperimental Treatment1 Intervention

A bipolar electrosurgical device that employs radiofrequency(RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger

Group II: Standard of careActive Control1 Intervention

In electrocautery tonsillectomy (or diathermy) electric current from a radiofrequency generator is passed through the tissue between two electrodes. The resulting high temperature (400º-600ºC) cuts the tissue and simultaneously seals the blood vessels

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,068 Total Patients Enrolled

Media Library

BiZact Clinical Trial Eligibility Overview. Trial Name: NCT04725305 — N/A

Tonsillectomy Research Study Groups: BiZact, Standard of care

Tonsillectomy Clinical Trial 2023: BiZact Highlights & Side Effects. Trial Name: NCT04725305 — N/A

BiZact 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725305 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this medical experiment?

"Affirmative. Clinicaltrials.gov evidences that this experiment, which was initialized on June 6th 2021, is opening its recruitment process to new participants. This trial requires 144 people from a single location for participation."

Answered by AI

Are there any vacancies in this clinical experiment that would accommodate new participants?

"Indeed, clinicaltrials.gov confirms that the study is actively addressing patient recruitment. It was initially posted on June 6th 2021 and revised for a final time on January 10th 2022 with an objective of enrolling 144 people at 1 site."

Answered by AI

What are the objectives of this experiment?

"The primary outcome, evaluated over the period of surgery time frame, is to measure emergency room visits. The secondary outcomes will record post-tonsillectomy hemorrhage - a common complication of tonsillectomy - through ER trips and follow-up questionnaires; operating time with both BiZact device and standard electrocautery; as well as pain medication use (ibuprofen every 6 hours for 5 days, acetaminophen in 4-6 hour intervals if needed, plus dexamethasone on Day 3, 4 or 5). Participants are asked to maintain accurate records of their use of these medications beyond day five"

Answered by AI

Recent research and studies

European Archives of Oto-Rhino-LaryngologyJournal

Post-tonsillectomy Hemorrhage: Assessment of Risk Factors with Special Attention to Introduction of Coblation Technique

Heidemann, Christian H., Mia Wallén, Marie Aakesson, Peter Skov, Anette D. Kjeldsen, and Christian Godballe. 2008. “Post-tonsillectomy Hemorrhage: Assessment of Risk Factors with Special Attention to Introduction of Coblation Technique”. European Archives of Oto-rhino-laryngology. Springer Science and Business Media LLC. doi:10.1007/s00405-008-0834-2.

Otolaryngology–Head and Neck SurgeryJournal

Clinical Practice Guideline: Tonsillectomy in Children

Baugh, Reginald F., Sanford M. Archer, Ron B. Mitchell, Richard M. Rosenfeld, Raouf Amin, James J. Burns, David H. Darrow, et al.. 2011. “Clinical Practice Guideline: Tonsillectomy in Children”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599810389949.

The LaryngoscopeJournal

Indications for Tonsillectomy and Adenoidectomy

Darrow, David H., and Christopher Siemens. 2009. “Indications for Tonsillectomy and Adenoidectomy”. The Laryngoscope. Wiley. doi:10.1002/lary.5541121404.

Otolaryngology–Head and Neck SurgeryJournal