Trials / Completed
CompletedNCT03266094
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- All
- Age
- 2 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy. Study Visits: * Screening/Baseline * Surgery, Day 0 * Post-Op Follow-up Day 1 - Day 7, Day 10, \& Day 14 (Home assessments) * Post-Op Follow-up Day 28 (Office Visit)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-09-30
- Primary completion
- 2019-06-21
- Completion
- 2019-07-11
- First posted
- 2017-08-29
- Last updated
- 2020-05-21
- Results posted
- 2020-05-12
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03266094. Inclusion in this directory is not an endorsement.