Trials / Unknown
UnknownNCT04320095
Tonsillectomy Using BiZact Tonsilletomy Device
BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- University of Calgary · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.
Detailed description
It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants. Operative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils. With regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bizact tonsillectomy device | Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage. |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-02-01
- Completion
- 2021-02-01
- First posted
- 2020-03-24
- Last updated
- 2020-03-31
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04320095. Inclusion in this directory is not an endorsement.