Tonsillectomy
Conditions
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)
Interventions
DEVICEA 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.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment Using a Visual Analog Scale (VAS) | Post-operative Day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Ability to return to Normal, subject's baseline, diet. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups: * Not at all: 1 * A little: 2 * Quite a bit: 3 * Very much: 4 |
| 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 | Ability to return to Normal, subject's baseline, activity. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups: * Not at all: 1 * A little: 2 * Quite a bit: 3 * Very much: 4 |
Countries
Sweden, United States
Participant flow
Recruitment details
A total of 48 Adults, greater than or equal to 22 in the US and greater than or equal to 18 in Europe, were enrolled into a single-arm trial. A total of 50 subjects were screened and consented and 2 subjects were withdrawn due to physician request.
Participants by arm
| Arm | Count |
|---|---|
| BiZact Arm 48 adults undergoing tonsillectomy | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | BiZact Arm |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 8.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment Sweden | 24 participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 23 Participants |
| Signed Informed Consent | 48 Participants |
| Undergoing Tonsillectomy | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 6 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
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
Time frame: Post-operative Day 1
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 1 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 5.4 units on a scale | Standard Deviation 2.59 |
Primary
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
Time frame: Post-operative Day 2
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 2 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 5.9 units on a scale | Standard Deviation 2.36 |
Primary
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
Time frame: Post-operative Day 3
Population: 45 out of 48 subjects completed the post-operative assessment as directed by the protocol, 3 subjects did not completed the assessment on day 3 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 6.1 units on a scale | Standard Deviation 2.05 |
Primary
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
Time frame: Post-operative Day 4
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 4 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 6.3 units on a scale | Standard Deviation 2.01 |
Primary
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
Time frame: Post-operative Day 5
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 5 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 6.3 units on a scale | Standard Deviation 2.16 |
Primary
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
Time frame: Post-operative Day 6
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 6 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 6.0 units on a scale | Standard Deviation 2.25 |
Primary
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
Time frame: Post-operative Day 7
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 7 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 4.9 units on a scale | Standard Deviation 2.54 |
Primary
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
Time frame: Post-operative Day 10
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 10 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 2.7 units on a scale | Standard Deviation 2.54 |
Primary
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
Time frame: Post-operative Day 14
Population: 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 14 as directed by the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | Pain Assessment Using a Visual Analog Scale (VAS) | 1.2 units on a scale | Standard Deviation 1.78 |
Secondary
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
Ability to return to Normal, subject's baseline, activity. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups: * Not at all: 1 * A little: 2 * Quite a bit: 3 * Very much: 4
Time frame: Post-operative Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | 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 | 12.4 days | Standard Deviation 2.77 |
Secondary
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
Ability to return to Normal, subject's baseline, diet. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups: * Not at all: 1 * A little: 2 * Quite a bit: 3 * Very much: 4
Time frame: Post-operative Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiZact Arm | 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 | 12.3 days | Standard Deviation 2.57 |