Tonsillectomy
Conditions
Brief summary
The purpose of this study is to assess safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.
Detailed description
A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy. Study Visits: * Screening/Baseline * Surgery, Day 0 * Post-Op Follow-up Day 1 - Day 7, Day 10, & Day 14 (Home assessments) * Post-Op Follow-up Day 28 (Office Visit)
Interventions
DEVICEBiZact™: 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.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive 2. Scheduled to undergo tonsillectomy 3. The subject and subject's Legally Authorized Representative (LAR) is willing to participate and consents to participate, as documented by signed informed consent form and/ or assent form (as applicable)
Exclusion criteria
1. Subjects undergoing: 1. Tonsillectomy as a result of cancer 2. Unilateral tonsillectomy 2. Subjects with: 1. Known Bleeding disorders 2. History of peritonsillar abscess 3. Craniofacial disorders 4. Down's syndrome (Trisomy 21) 5. Cerebral palsy 6. 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.) 7. Current tobacco use 3. Subjects unable to comply with the required study follow-up visits 4. Female subjects pregnant at time of procedure 5. 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. 6. The subject is participating or has participated in any drug or device research study within 30 days of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative Blood Loss | During procedure | The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis |
| Number of Patients With Intra-operative Blood Loss | During procedure | The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device | During Procedure | Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor). |
| Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device) | During Procedure | Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures) |
| Number of Cases/Participants With Analgesic Consumption | 28 days post-operatively | Analgesic consumption (standard of care) and concomitant medications (via patient diary). |
| Post-operative Pain | Post-operative Day 4 | Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst. |
Countries
United States
Participant flow
Recruitment details
A total of 60 children, ages 2 to 12 in the US, were enrolled into a single-arm trial. A total of 60 subjects were screened and consented.
Participants by arm
| Arm | Count |
|---|---|
| BiZact Arm 60 Pediatric subjects undergoing tonsillectomy | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | BiZact Arm |
|---|---|
| Age, Categorical <=18 years | 60 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6.7 years STANDARD_DEVIATION 2.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 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 | 51 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 22 Participants |
| Signed Informed Consent | 60 Participants |
| Undergoing Tonsillectomy | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 27 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Intra-operative Blood Loss
The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
Time frame: During procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Intra-operative Blood Loss | 1.7 mL | Standard Deviation 2.38 |
Primary
Number of Patients With Intra-operative Blood Loss
The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
Time frame: During procedure
Population: Intra-operative bleeding occurred in 29 of the 60 patients. For subjects with no intra-operative bleeding, volume was considered as 0 mL.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Number of Patients With Intra-operative Blood Loss | Patients with Intra-operative bleeding | 29 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Patients With Intra-operative Blood Loss | Patients age 3-5 | 9 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Patients With Intra-operative Blood Loss | Patients age 6-12 | 20 Participants |
Secondary
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).
Time frame: During Procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device | Very Good | 51 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device | Good | 6 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device | Acceptable | 1 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device | Poor | 1 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device | Very Poor | 1 Participants |
Secondary
Number of Cases/Participants With Analgesic Consumption
Analgesic consumption (standard of care) and concomitant medications (via patient diary).
Time frame: 28 days post-operatively
Population: Caregivers were instructed to complete the take-home diary and record analgesics given on days 1-6, 7, 10, 14, and 28. Compliance with completing the diaries was not 100% and therefore we do not have data for all 60 subjects. Missing data was recorded as a protocol deviation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 0 | 58 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 1 | 56 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 2 | 55 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 3 | 54 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 4 | 53 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 5 | 49 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 6 | 49 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 7 | 44 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 10 | 19 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 14 | 6 Participants |
| A Bipolar Instrument for Tonsillectomies | Number of Cases/Participants With Analgesic Consumption | Day 28 | 1 Participants |
Secondary
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures)
Time frame: During Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device) | 60 Participants |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Post-operative Day 10
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 10, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 1.5 score on a scale | Standard Deviation 2.16 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Post-operative Day 14
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 56 caregivers completed the diary for day 14, so only 56 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 0.8 score on a scale | Standard Deviation 1.82 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Post-operative Day 28
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 28, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 0.3 score on a scale | Standard Deviation 1.18 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Day 1
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 1, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 5.4 score on a scale | Standard Deviation 2.94 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Day 2
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 2, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 5.1 score on a scale | Standard Deviation 2.83 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Day 3
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 3, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 4.9 score on a scale | Standard Deviation 2.83 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Post-operative Day 4
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 4, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 4.7 score on a scale | Standard Deviation 2.93 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Post-operative Day 5
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 5, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 4.5 score on a scale | Standard Deviation 2.79 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Post-operative Day 6
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 6, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 3.7 score on a scale | Standard Deviation 2.61 |
Secondary
Post-operative Pain
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 No Hurt to a crying face at 10 Hurts Worst.
Time frame: Post-operative Day 7
Population: Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 53 caregivers completed the diary for day 7, so only 53 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Bipolar Instrument for Tonsillectomies | Post-operative Pain | 3.3 score on a scale | Standard Deviation 2.83 |