Trial Outcomes & Findings for A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy (NCT NCT03266094)
NCT ID: NCT03266094
Last Updated: 2020-05-21
Results Overview
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
COMPLETED
NA
60 participants
During procedure
2020-05-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Baseline characteristics by cohort
| Measure |
BiZact Arm
n=60 Participants
60 Pediatric subjects undergoing tonsillectomy
|
|---|---|
|
Age, Categorical
<=18 years
|
60 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.7 years
STANDARD_DEVIATION 2.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
|
Undergoing Tonsillectomy
|
60 Participants
n=5 Participants
|
|
Signed Informed Consent
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During procedureThe 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
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=60 Participants
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.
BiZact™: 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.
|
|---|---|
|
Intra-operative Blood Loss
|
1.7 mL
Standard Deviation 2.38
|
PRIMARY outcome
Timeframe: During procedurePopulation: Intra-operative bleeding occurred in 29 of the 60 patients. For subjects with no intra-operative bleeding, volume was considered as 0 mL.
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
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=29 Participants
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.
BiZact™: 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.
|
|---|---|
|
Number of Patients With Intra-operative Blood Loss
Patients with Intra-operative bleeding
|
29 Participants
|
|
Number of Patients With Intra-operative Blood Loss
Patients age 3-5
|
9 Participants
|
|
Number of Patients With Intra-operative Blood Loss
Patients age 6-12
|
20 Participants
|
SECONDARY outcome
Timeframe: During ProcedureAbility to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=60 Participants
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.
BiZact™: 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.
|
|---|---|
|
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Very Good
|
51 Participants
|
|
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Good
|
6 Participants
|
|
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Acceptable
|
1 Participants
|
|
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Poor
|
1 Participants
|
|
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Very Poor
|
1 Participants
|
SECONDARY outcome
Timeframe: During ProcedureAbility 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)
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=60 Participants
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.
BiZact™: 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.
|
|---|---|
|
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
|
60 Participants
|
SECONDARY outcome
Timeframe: 28 days post-operativelyPopulation: 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.
Analgesic consumption (standard of care) and concomitant medications (via patient diary).
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=60 Participants
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.
BiZact™: 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.
|
|---|---|
|
"Number of Cases/Participants With Analgesic Consumption
Day 0
|
58 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 1
|
56 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 2
|
55 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 3
|
54 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 4
|
53 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 5
|
49 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 6
|
49 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 7
|
44 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 10
|
19 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 14
|
6 Participants
|
|
"Number of Cases/Participants With Analgesic Consumption
Day 28
|
1 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 4Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=58 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
4.7 score on a scale
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: Post-operative Day 5Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=58 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
4.5 score on a scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Post-operative Day 6Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=57 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
3.7 score on a scale
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Post-operative Day 7Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=53 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
3.3 score on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Post-operative Day 10Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=57 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
1.5 score on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Post-operative Day 14Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=56 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
0.8 score on a scale
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: Post-operative Day 28Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=57 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
0.3 score on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=58 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
5.4 score on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Day 2Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=58 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
5.1 score on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
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".
Outcome measures
| Measure |
A Bipolar Instrument for Tonsillectomies
n=58 Participants
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.
BiZact™: 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.
|
|---|---|
|
Post-operative Pain
|
4.9 score on a scale
Standard Deviation 2.83
|
Adverse Events
BiZact Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BiZact Arm
n=60 participants at risk
60 Pediatric subjects undergoing tonsillectomy
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Right Knee Injury
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Infections and infestations
Fever
|
5.0%
3/60 • Number of events 3 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Infections and infestations
Influenza
|
5.0%
3/60 • Number of events 3 • 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.
|
|
Injury, poisoning and procedural complications
Swollen Tongue
|
3.3%
2/60 • Number of events 2 • 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.
|
|
Infections and infestations
Cold
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Infections and infestations
Headache
|
3.3%
2/60 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Viral Gastroenteritis
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Head Laceration
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Ear and labyrinth disorders
Bilateral Inferior Turbinate Hypertrophy
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Infections and infestations
Cough
|
3.3%
2/60 • Number of events 2 • 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.
|
|
Ear and labyrinth disorders
Ear Pain
|
6.7%
4/60 • Number of events 4 • 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.
|
|
Infections and infestations
Strep Throat
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Infections and infestations
Bronchitis
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Dehydration
|
6.7%
4/60 • Number of events 5 • 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.
|
|
Injury, poisoning and procedural complications
Significant Pain in Throat
|
3.3%
2/60 • Number of events 2 • 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.
|
|
Infections and infestations
Ear Infection
|
1.7%
1/60 • Number of events 1 • 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.
|
|
Nervous system disorders
Epistaxis
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3.3%
2/60 • Number of events 2 • 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.
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Additional Information
Melody LaBeau, Director of Clinical Operations
Medtronic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60