A Study of BiZact™ on Adults Undergoing Tonsillectomy

NCT ID: NCT02876575

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2018-10-24

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.

Detailed Description

Study Design: Prospective, multi-center, single-arm non-comparative pilot study to assess the severity of post-operative pain with the use of BiZact™ for tonsillectomy.

Study Visits:

• Screening
• Surgery, Day 0
• Post-Op Follow-up Day 1 - Day 7 & Day 10 (Home assessments)
• Post-Op Follow-up Day 14 (Office Visit)

Conditions

Tonsillectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

A bipolar instrument for tonsillectomies

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adults (male or female) ≥22 in United States and ≥18 years of age in Europe years of age

2. Scheduled to undergo tonsillectomy

3. Signed informed consent by subject

Exclusion Criteria

1. Subjects undergoing:

1. Simultaneous adenoidectomy

2. Tonsillectomy as a result of cancer

3. Unilateral tonsillectomy

4. Current participation in other clinical trials

2. Subjects with:

1. Current tobacco use

2. Known bleeding disorders

3. History of peritonsillar abscess

4. Craniofacial disorders

5. Down syndrome (Trisomy 21)

6. Cerebral palsy

7. 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.)

8. Subjects unable to comply with the required study follow-up visits

9. Pregnancy

3. The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months

4. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)

5. The subject has participated in any drug or device research study within 30 days of enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Karni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Houston

Locations

UT Health

Houston, Texas, United States

Sophia Hemmet

Stockholm, , Sweden

Countries

United States; Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COVBZTS0562

Identifier Type: -

Identifier Source: org_study_id