Trial Outcomes & Findings for A Study of BiZact™ on Adults Undergoing Tonsillectomy (NCT NCT02876575)

Last Updated: 2020-04-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

Post-operative Day 1

Results posted on

2020-04-07

Participant Flow

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 A total of 50 subjects were screened and consented and 2 subjects were withdrawn due to physician request.

Participant milestones

Participant milestones
Measure	BiZact Arm 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.
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of BiZact™ on Adults Undergoing Tonsillectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BiZact Arm n=48 Participants 48 adults undergoing tonsillectomy
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years STANDARD_DEVIATION 8.78 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 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	2 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	7 Participants n=5 Participants
Race (NIH/OMB) White	39 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 Sweden	24 participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
Undergoing Tonsillectomy	48 Participants n=5 Participants
Signed Informed Consent	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	5.4 units on a scale Standard Deviation 2.59

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	5.9 units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=45 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	6.1 units on a scale Standard Deviation 2.05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	6.3 units on a scale Standard Deviation 2.01

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	6.3 units on a scale Standard Deviation 2.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	6.0 units on a scale Standard Deviation 2.25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	4.9 units on a scale Standard Deviation 2.54

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	2.7 units on a scale Standard Deviation 2.54

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BiZact Arm n=46 Participants 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.
Pain Assessment Using a Visual Analog Scale (VAS)	1.2 units on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	BiZact Arm n=48 Participants 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.
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

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	BiZact Arm n=48 Participants 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.
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

Adverse Events

BiZact Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BiZact Arm n=48 participants at risk 48 adults undergoing tonsillectomy
Injury, poisoning and procedural complications Post-Tonsillectomy Hemorrhage	10.4% 5/48 • Number of events 6 • Adverse Events were collects from baseline and day 0 to 14 days follow up In alignment with ISO 14155:2011 (Section 3.2), an Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device and the procedures involved.
Injury, poisoning and procedural complications Pain	2.1% 1/48 • Number of events 1 • Adverse Events were collects from baseline and day 0 to 14 days follow up In alignment with ISO 14155:2011 (Section 3.2), an Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device and the procedures involved.

Additional Information

Melody LaBeau, Director of Clinical Operations

Medtronic

Phone: 7635262931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Medical Center /Investigator may publish the results of work performed under this Agreement, in accordance with the Publication Policy described in the Clinical Investigation Plan and publication guidelines from the Declaration of Helsinki; provided, however, that any such Publication shall be at a time determined by Medtronic and shall be provided to Medtronic for review at least sixty (60) days prior to submission or presentation.
Publication restrictions are in place

Restriction type: OTHER