Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy.
Study Visits:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A bipolar instrument for tonsillectomies | Other | A bipolar electrosurgical device that employs Radio frequency (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiZact™: A bipolar instrument for tonsillectomies | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During procedure |
| 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 | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During Procedure |
| Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects undergoing:
Subjects with:
Subjects unable to comply with the required study follow-up visits
Female subjects pregnant at time of procedure
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.
The subject is participating or has participated in any drug or device research study within 30 days of enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eugene Brown, MD | Coastal Pediatric Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Clinical Research Associates, LLC | Charlotte | North Carolina | 28210 | United States | ||
| Coastal Pediatric Associates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BiZact Arm | A bipolar electrosurgical device that employs Radio frequency (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
During the study, 60 patients were screened, and 60 patients were consented and enrolled in the study. One patient was lost to follow-up. Another patient withdrew from the study during post-procedure follow-up. Both patients were still included in the intent-to-treat data analysis with the data obtained.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BiZact Arm | 60 Pediatric subjects undergoing tonsillectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mL | During procedure |
|
Day 0 (after commencement of surgery with BiZact™ to 28 (+7) days follow-up
Definition of adverse event is consistent with clinicaltrials.gov.
The relationship to the study-device was "not related" for 100% of Adverse Event (AE) reports. There have been no serious adverse events, unanticipated adverse device effects, unanticipated serious adverse device effects reported in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BiZact Arm | 60 Pediatric subjects undergoing tonsillectomy | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Knee Injury | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melody LaBeau, Director of Clinical Operations | Medtronic | 763.526.2931 | melody.a.labeau@medtronic.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 | Jan 6, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) |
| During Procedure |
| "Number of Cases/Participants With Analgesic Consumption | Analgesic consumption (standard of care) and concomitant medications (via patient diary). | 28 days post-operatively |
| 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". | Post-operative Day 4 |
| 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". | Post-operative Day 5 |
| 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". | Post-operative Day 6 |
| 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". | Post-operative Day 7 |
| 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". | Post-operative Day 10 |
| 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". | Post-operative Day 14 |
| 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". | Post-operative Day 28 |
| 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". | Day 1 |
| 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". | Day 2 |
| 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". | Day 3 |
| Charleston |
| South Carolina |
| 29407 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Undergoing Tonsillectomy | Count of Participants | Participants |
|
| Signed Informed Consent | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | Intra-operative bleeding occurred in 29 of the 60 patients. For subjects with no intra-operative bleeding, volume was considered as 0 mL. | Posted | Count of Participants | Participants | During procedure |
|
|
|
| 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). | Posted | Count of Participants | Participants | During Procedure |
|
|
|
| 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) | Posted | Count of Participants | Participants | During Procedure |
|
|
|
| Secondary | "Number of Cases/Participants With Analgesic Consumption | Analgesic consumption (standard of care) and concomitant medications (via patient diary). | 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. | Posted | Count of Participants | Participants | 28 days post-operatively |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 4 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 5 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 6 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 7 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 10 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 14 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 28 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 2 |
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 3 |
|
|
|
| 60 |
| 0 |
| 60 |
| 27 |
| 60 |
| Fever | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Swollen Tongue | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Cold | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Headache | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Viral Gastroenteritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Head Laceration | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Bilateral Inferior Turbinate Hypertrophy | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cough | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Strep Throat | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Dehydration | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Significant Pain in Throat | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Epistaxis | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Poor |
|
| Very Poor |
|
|
| Day 2 |
|
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 10 |
|
|
| Day 14 |
|
|
| Day 28 |
|
|