Trial Outcomes & Findings for PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy (NCT NCT01193556)

Results Overview

The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

10 days immediately following surgery

Results posted on

2013-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care (SOC) Traditional electrosurgery will be used for the tonsillectomy.	PlasmaBlade The PEAK PlasmaBlade will be used for the tonsillectomy.
Overall Study STARTED	26	25
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	26	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care (SOC) Traditional electrosurgery will be used for the tonsillectomy.	PlasmaBlade The PEAK PlasmaBlade will be used for the tonsillectomy.
Overall Study Study termination	26	25

Baseline Characteristics

PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care (SOC) n=26 Participants Traditional electrosurgery will be used for the tonsillectomy.	PlasmaBlade n=25 Participants The PEAK PlasmaBlade will be used for the tonsillectomy.	Total n=51 Participants Total of all reporting groups
Age, Customized Children (3-17 years)	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants
Age, Customized Adults (18 years and older)	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Gender Female	NA partipants n=5 Participants	NA partipants n=7 Participants	0 partipants n=5 Participants
Gender Male	NA partipants n=5 Participants	NA partipants n=7 Participants	0 partipants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	25 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days immediately following surgery

Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.

The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-2 weeks post-operatively

Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PlasmaBlade

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care (SOC) n=26 participants at risk Traditional electrosurgery will be used for the tonsillectomy.	PlasmaBlade n=25 participants at risk The PEAK PlasmaBlade will be used for the tonsillectomy.
Surgical and medical procedures Postoperative bleeding	0.00% 0/26	4.0% 1/25 • Number of events 1

Other adverse events

Other adverse events
Measure	Standard of Care (SOC) n=26 participants at risk Traditional electrosurgery will be used for the tonsillectomy.	PlasmaBlade n=25 participants at risk The PEAK PlasmaBlade will be used for the tonsillectomy.
Gastrointestinal disorders Nausea/vomiting	0.00% 0/26	8.0% 2/25 • Number of events 2
Surgical and medical procedures Postoperative bleeding	0.00% 0/26	8.0% 2/25 • Number of events 2

Additional Information

Robert Swain, PhD

Medtronic Surgical Technologies

Phone: (+1-603) 294-5428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60