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BiZact Tonsillectomy in the Pediatric Population

NCT04725305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-07-29

No results posted yet for this study

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

Interventions

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

PROCEDURE

Standard of care

This method would involve removal of tonsils using electrocautery technique

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-06
Primary Completion
2024-07-25
Completion
2024-07-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04725305 on ClinicalTrials.gov