Tonsillitis
Conditions
Keywords
Tonsillectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
Brief summary
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).
Detailed description
Tonsillectomy is performed in response to cases of repeated occurrence of acute tonsillitis or adenoiditis, obstructive sleep apnea, nasal airway obstruction, snoring, or peritonsillar abscess. The PEAK PlasmaBlade uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing tonsillectomy. Two study sites were granted approval for this prospective randomized study. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent for themselves (adults) or for their child prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for tonsillectomy or tonsillectomy and adenoidectomy (TnA).
Interventions
DEVICEPEAK PlasmaBlade TnA
The PEAK PlasmaBlade will be used for the tonsillectomy.
Traditional electrosurgery for the tonsillectomy.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Children & adolescents: Age 3-17; Adults: 18 and older 2. Physically healthy, stable weight 3. Requiring tonsillectomy and adenoidectomy per widely accepted indications 4. For adults, subject must understand the nature of the procedure and provide written informed consent. 5. For children and adolescents age 7 to 17, subject must understand the nature of the procedure and be able to give verbal assent prior to the procedure. In addition, parent or guardian must provide written informed consent. 6. For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent. 7. Subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets.
Exclusion criteria
1. Children: Age 2 and under 2. Bleeding disorder 3. Peritonsillar abscess 4. Requiring concomitant uvulopalatopharyngoplasty (UPPP) 5. Anticoagulation therapy which cannot be discontinued 6. Unable to follow instructions or complete follow-up 7. Currently taking any medication known to affect healing 8. Currently enrolled in another investigational device or drug trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | 10 days immediately following surgery | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level | 1-2 weeks post-operatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SOC) Traditional electrosurgery will be used for the tonsillectomy. | 26 |
| PlasmaBlade The PEAK PlasmaBlade will be used for the tonsillectomy. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study termination | 26 | 25 |
Baseline characteristics
| Characteristic | Standard of Care (SOC) | PlasmaBlade | Total |
|---|---|---|---|
| Age, Customized Adults (18 years and older) | 12 participants | 12 participants | 24 participants |
| Age, Customized Children (3-17 years) | 14 participants | 13 participants | 27 participants |
| Gender Female | NA partipants | NA partipants | 0 partipants |
| Gender Male | NA partipants | NA partipants | 0 partipants |
| Region of Enrollment United States | 26 participants | 25 participants | 51 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 4 / 25 |
| serious Total, serious adverse events | 0 / 26 | 1 / 25 |
Outcome results
Primary
Post-operative Pain
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.
Time frame: 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.
Secondary
Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level
Time frame: 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.