A Study of BiZact™ on Adults Undergoing Tonsillectomy

Medtronic

Status: Completed

Conditions: Tonsillectomy

Treatments: Device: A bipolar instrument for tonsillectomies

Study type: Interventional

Funder types: Industry

Identifiers

NCT02876575

COVBZTS0562

Details and patient eligibility

About

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.

Full 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)

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

A bipolar instrument for tonsillectomies

Other group

Description:

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.

Treatment:

Device: A bipolar instrument for tonsillectomies