Tonsillectomy Using BiZact Tonsilletomy Device

Tonsillectomy Clinical Trial

Official title:

BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04320095
• Other study ID #: REB19-0088
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: February 2021

Study information

• Verified date: March 2020
• Source: University of Calgary
• Contact: Khaloud Al Bahri, MD
• Phone: 587-888-1284
• Email: khaloud.albahri[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Children scheduled for tonsillectomy at Alberta Children Hospital

2. Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.

Exclusion Criteria:

1. Craniofacial abnormalities

2. Bleeding disorders

3. Complex medical background

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery	during the procedure
Secondary	Intraoperative blood loss	The study will be considered success if the mean intraoperative blood loss using Bizact is less than Electrocautery	during the procedure