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BiZact Tonsillectomy in the Pediatric Population

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ClinicalTrials.gov Identifier: NCT04725305
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Ronald Vilela, Baylor College of Medicine

Brief Summary:
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy

Condition or disease Intervention/treatment Phase
Tonsillectomy Tonsillitis Chronic Hemorrhage Postoperative Pain Postoperative Hemorrhage Surgery--Complications Otorhinolaryngologic Diseases Device: BiZact Procedure: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups of participants will receive different interventions. One arm will receive the standard of care ( electrocautery) and the other group will receive the BIZACT method of tonsillectomy. The group allocation will be carried out by stratified randomization.
Masking: Single (Participant)
Masking Description: The participant will not be aware of the arm that the participate will be placed in- i.e. whether the tonsillectomy was carried out by electrocautery or using the BiZact device
Primary Purpose: Treatment
Official Title: BiZact Tonsillectomy
Actual Study Start Date : June 6, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Tonsillitis

Arm Intervention/treatment
Experimental: BiZact
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
Device: BiZact
It has been described as describes a bipolar device that continuously measures impedance of clamped tissue, adjusting energy levels in real time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain

Active Comparator: Standard of care
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
Procedure: Standard of care
This method would involve removal of tonsils using electrocautery technique




Primary Outcome Measures :
  1. Emergency room visits [ Time Frame: 2 months ]
    Emergency room visits following tonsillectomy commonly involve poorly controlled pain, dehydration, and post-tonsillectomy hemorrhage. The investigators will tabulate the number of ER visits related to post-operative factors by reviewing charts of tonsillectomy patients two months post-operatively.

  2. Intra-operative blood loss [ Time Frame: Duration of surgery ]
    Intra-operative blood loss will be recorded in milliliters for all patients undergoing tonsillectomy using the BiZact device. Additionally, each surgeon using the Bi-zact device will maintain records of intra-operative blood loss in milliliters for tonsillectomies utilizing standard electrocautery for tonsillectomy.


Secondary Outcome Measures :
  1. Post-tonsillectomy hemorrhage [ Time Frame: 2 months ]
    Post-tonsillectomy hemorrhage is a known complication of tonsillectomy. The investigators will tabulate the incidence of post-tonsillectomy hemorrhage by reviewing emergency room visits in the post-operative period and through follow-up questionnaires at the first post-operative clinic visit.

  2. Pain level [ Time Frame: 14 days ]
    Patients will be asked to maintain a pain diary. The investigators will ask the parent or caretaker to document the Wong-Baker FACES Pain Rating Scale twice a day for fourteen days.

  3. Pain medication documentation [ Time Frame: 5 days ]
    Post-operative pain protocol at Texas Children's Hospital includes scheduled weight-based doses of ibuprofen every 6 hours for 5 days, acetaminophen every 4-6 hours as needed, and a one-time dose of dexamethasone as needed to be given on post-operative day 3, 4, or 5 for breakthrough pain. Patients are also instructed to use ibuprofen as needed for pain after the first 5 days. Participants will be instructed to maintain accurate records of use of acetaminophen and dexamethasone use, and use of ibuprofen beyond 5 days post-operatively

  4. Operating time [ Time Frame: Duration of procedure ]
    Operative time in minutes will be recorded for all patients undergoing tonsillectomy using the BiZact device. Additionally, each surgeon using the BiZact device will maintain records of operative time using standard electrocautery for tonsillectomy



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tonsil hypertrophy with sleep disordered breathing
  • Recurrent tonsillitis or pharyngitis
  • Tonsil asymmetry or neoplasm
  • Tonsil stones
  • Must be able to take ibuprofen

Exclusion Criteria:

  • Bleeding disorders such as von Willebrand's disease or hemophilia
  • Down's Syndrome or other craniofacial syndromes
  • Revision tonsillectomy cases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725305


Contacts
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Contact: Ronald Vilela, M.D 832-822-3268 rjvilela@texaschildrens.org
Contact: Grace Shebha Anand, MPH 8328221980 gxanand@texaschildrens.org

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ronald Vilela, MD    832-822-3268    rjvilela@texaschildrens.org   
Contact: Grace Anand, MPH    8328221980    gxanand@texaschildrens.org   
Sub-Investigator: Daniel Chelius, MD         
Sub-Investigator: Shraddha Mukerji, MD         
Sub-Investigator: Carol Yi-Chun Liu, MD         
Sub-Investigator: Matthew D Chelius, MD         
Sub-Investigator: Sonal Saraiya, MD         
Sub-Investigator: Jeff Carter         
Sub-Investigator: Alexis Moisiuc         
Sponsors and Collaborators
Baylor College of Medicine
Publications:
Medtronic Brief: More efficient tonsillectomies. Boulder Colorado, 2017. Retrieved from http://www.medtronic.com/content/dam/covidien/library/us/en/product/vessel-sealing/bizact-tonsillectomy-device-product-information-kit.pdf, 9/23/18.

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Responsible Party: Ronald Vilela, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04725305    
Other Study ID Numbers: H-44399
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ronald Vilela, Baylor College of Medicine:
tonsillectomy
Bizact
Additional relevant MeSH terms:
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Tonsillitis
Otorhinolaryngologic Diseases
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases