BiZact Tonsillectomy in the Pediatric Population

NCT04725305 | Completed FDA Device

• 1 other identifier: H-44399
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

Tonsillectomy; Tonsillitis Chronic; Hemorrhage; Postoperative Pain; Postoperative Hemorrhage; Surgery--Complications; Otorhinolaryngologic Diseases

Keywords

tonsillectomy; Bizact

Outcome Measures

Primary Outcomes (2)

• Emergency room visits

  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 months

• Intra-operative blood loss

  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.

  Duration of surgery

Secondary Outcomes (4)

• Post-tonsillectomy hemorrhage

  2 months

• Pain level

  14 days

• Pain medication documentation

  5 days

• Operating time

  Duration of procedure

Study Arms (2)

BiZact

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

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

Interventions

BiZact DEVICE

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

BiZact

Standard of care PROCEDURE

This method would involve removal of tonsils using electrocautery technique

Standard of care

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (11)

• Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.

  PMID: 28256998 BACKGROUND

• Rosenfeld RM, Green RP. Tonsillectomy and adenoidectomy: changing trends. Ann Otol Rhinol Laryngol. 1990 Mar;99(3 Pt 1):187-91.

  PMID: 2178542 BACKGROUND

• De Luca Canto G, Pacheco-Pereira C, Aydinoz S, Bhattacharjee R, Tan HL, Kheirandish-Gozal L, Flores-Mir C, Gozal D. Adenotonsillectomy Complications: A Meta-analysis. Pediatrics. 2015 Oct;136(4):702-18. doi: 10.1542/peds.2015-1283. Epub 2015 Sep 21.

  PMID: 26391937 BACKGROUND

• Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.

  PMID: 21493257 BACKGROUND

• Nunez DA, Provan J, Crawford M. Postoperative tonsillectomy pain in pediatric patients: electrocautery (hot) vs cold dissection and snare tonsillectomy--a randomized trial. Arch Otolaryngol Head Neck Surg. 2000 Jul;126(7):837-41. doi: 10.1001/archotol.126.7.837.

  PMID: 10888995 BACKGROUND

• Jones DT, Kenna MA, Guidi J, Huang L, Johnston PR, Licameli GR. Comparison of postoperative pain in pediatric patients undergoing coblation tonsillectomy versus cautery tonsillectomy. Otolaryngol Head Neck Surg. 2011 Jun;144(6):972-7. doi: 10.1177/0194599811400369. Epub 2011 Apr 4.

  PMID: 21493315 BACKGROUND

• Heidemann CH, Wallen M, Aakesson M, Skov P, Kjeldsen AD, Godballe C. Post-tonsillectomy hemorrhage: assessment of risk factors with special attention to introduction of coblation technique. Eur Arch Otorhinolaryngol. 2009 Jul;266(7):1011-5. doi: 10.1007/s00405-008-0834-2. Epub 2008 Oct 25.

  PMID: 18953553 BACKGROUND

• Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008 Aug;139(2):228-34. doi: 10.1016/j.otohns.2008.04.004.

  PMID: 18656720 BACKGROUND

• Pizzuto MP, Brodsky L, Duffy L, Gendler J, Nauenberg E. A comparison of microbipolar cautery dissection to hot knife and cold knife cautery tonsillectomy. Int J Pediatr Otorhinolaryngol. 2000 May 30;52(3):239-46. doi: 10.1016/s0165-5876(00)00293-7.

  PMID: 10841953 BACKGROUND

• 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.

  BACKGROUND

• Krishnan G, Stepan L, Du C, Padhye V, Bassiouni A, Dharmawardana N, Ooi EH, Krishnan S. Tonsillectomy using the BiZact: A pilot study in 186 children and adults. Clin Otolaryngol. 2019 May;44(3):392-396. doi: 10.1111/coa.13273. Epub 2019 Feb 4. No abstract available.

  PMID: 30576062 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Pain, Postoperative; Postoperative Hemorrhage; Otorhinolaryngologic Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: January 26, 2021
• Study Start: June 6, 2021
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)