What side effects are associated with this type of intervention?

The Bizact Tonsillectomy Device, which has been shown to reduce blood loss and shorten surgery time, shares common side effects with other tonsillectomy procedures. These side effects include postoperative pain, risk of infection, difficulty swallowing, and dehydration. Additionally, bleeding is a potential complication, although the rate of postoperative bleeding is similar to other tonsillectomy methods. It is important for patients to discuss these risks with their healthcare provider to ensure a comprehensive understanding of the procedure and its potential outcomes.

What prior FDA approvals exist?

The Bizact Tonsillectomy Device, studied in 2019, demonstrated effectiveness in reducing blood loss and shortening surgery time during tonsillectomies. While specific FDA approvals for similar devices are not detailed in the provided context, traditional tonsillectomy methods typically involve standard surgical instruments and techniques aimed at minimizing complications. The Bizact device represents an advancement in this area by offering improved surgical efficiency and reduced intraoperative blood loss.

What other types of research exist?

As of 2024, promising alternatives to the Bizact Tonsillectomy Device include the use of coblation technology and harmonic scalpel tonsillectomy. Coblation technology uses radiofrequency energy to dissolve tissue at low temperatures, which can reduce blood loss and minimize thermal damage. The harmonic scalpel uses ultrasonic vibrations to cut and coagulate tissue simultaneously, potentially reducing operative time and intraoperative bleeding. Both techniques have shown efficacy in improving surgical outcomes in tonsillectomy patients.

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BiZact Device for Tonsillectomy

N/A

Waitlist Available

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

Must not have

Revision tonsillectomy cases

Bleeding disorders such as von Willebrand's disease or hemophilia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the Bizact device for tonsil removal in children and adults. The device aims to make the surgery faster and reduce complications like blood loss by using less heat. Early results show it may reduce operating time and blood loss compared to traditional methods. The BiZact™ device has been evaluated for its learning curve and effectiveness in reducing operative time and blood loss in tonsillectomies.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having a second tonsillectomy.

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I have a bleeding disorder like von Willebrand's or hemophilia.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Emergency room visits

Intra-operative blood loss

Secondary study objectives

Operating time

Pain level

Pain medication documentation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BiZact

2021

N/A

~150

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Bizact tonsillectomy device operates by simultaneously cutting and coagulating tissue, which reduces intraoperative blood loss and shortens the duration of the surgery. This is significant for tonsillectomy patients as it minimizes the risk of bleeding and reduces the overall time under anesthesia, potentially leading to quicker recovery times. Similarly, coblation tonsillectomy uses radiofrequency energy to dissolve tissue at low temperatures, resulting in less pain and blood loss compared to traditional methods. Cold dissection, on the other hand, involves physically cutting the tonsils with minimal thermal damage, which can also reduce postoperative pain and bleeding. These advanced techniques are important as they aim to improve patient outcomes by reducing complications and enhancing recovery.

Coblation versus cold dissection in paediatric tonsillectomy: a systematic review and meta-analysis.