Brief Summary

The purpose of this study is to assess the severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Feb 2017

Geographic Reach

2 countries

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

July 29, 2016

Completed

26 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed

6 months until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

December 26, 2019

Completed

Last Updated

April 7, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

July 29, 2016

Results QC Date

November 5, 2019

Last Update Submit

March 30, 2020

Conditions

Tonsillectomy

Outcome Measures

Primary Outcomes (9)

Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 1
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 2
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 3
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 4
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 5
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 6
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 7
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 10
Pain Assessment Using a Visual Analog Scale (VAS)
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
Post-operative Day 14

Secondary Outcomes (2)

Time to Normal Diet Following the Use of the BiZact™ Device in Adult (≥22 Years of Age in United States and ≥18 Years of Age in Europe) Tonsillectomy Procedures
Post-operative Day 28
Time to Normal Activity Following the Use of the BiZact™ Device in Adult (≥22 Years of Age in United States and ≥18 Years of Age in Europe) Tonsillectomy Procedures
Post-operative Day 28

Study Arms (1)

A bipolar instrument for tonsillectomies

OTHER

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.

Device: A bipolar instrument for tonsillectomies

Interventions

A bipolar instrument for tonsillectomiesDEVICE

A bipolar instrument for tonsillectomies

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults (male or female) ≥22 in United States and ≥18 years of age in Europe years of age
Scheduled to undergo tonsillectomy
Signed informed consent by subject

You may not qualify if:

Subjects undergoing:
Simultaneous adenoidectomy
Tonsillectomy as a result of cancer
Unilateral tonsillectomy
Current participation in other clinical trials
Subjects with:
Current tobacco use
Known bleeding disorders
History of peritonsillar abscess
Craniofacial disorders
Down syndrome (Trisomy 21)
Cerebral palsy
Major heart disease (including but not limited to; right-sided heart failure, left-sided heart failure, congestive heart failure, coronary artery disease, arrhythmias, chronic heart failure, acute heart failure, etc.)
Subjects unable to comply with the required study follow-up visits
Pregnancy
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Medtronic - MITGlead

Study Sites (2)

UT Health

Houston, Texas, 77030, United States

Location

Sophia Hemmet

Stockholm, Sweden

Location

MeSH Terms

Interventions

Tonsillectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title: Melody LaBeau, Director of Clinical Operations
Organization: Medtronic

Study Officials

Ron Karni, MD
University of Texas at Houston
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 24, 2016

Study Start

February 13, 2017

Primary Completion

October 24, 2018

Study Completion

October 24, 2018

Last Updated

April 7, 2020

Results First Posted

December 26, 2019

Record last verified: 2020-03

Data Sharing

IPD Sharing: Will not share

Locations

US(1)SE(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (2)

Study Arms (1)

A bipolar instrument for tonsillectomies

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations