MedTrace Logo

A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

NCT03266094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-21

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.

Conditions

  • Tonsillectomy

Interventions

DEVICE

BiZact™: A bipolar instrument for tonsillectomies

A bipolar electrosurgical device that employs 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.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Eugene Brown, MD · Coastal Pediatric Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-06-21
Completion
2019-07-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03266094 on ClinicalTrials.gov