TonsillitisPRECISENCT01193556
PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
A study testing PEAK PlasmaBlade TnA and Traditional Electrosurgery with scalpel in people with Tonsillitis, run by Medtronic Surgical Technologies at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Tonsillitis
- What is being tested?
- PEAK PlasmaBlade TnA and Traditional Electrosurgery with scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children \& adolescents: Age 3-17; Adults: 18 and older
- Physically healthy, stable weight
- Requiring tonsillectomy and adenoidectomy per widely accepted indications
- For adults, subject must understand the nature of the procedure and provide written informed consent.
- 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.
- For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent.
- Subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets.
Who cannot join
- Children: Age 2 and under
- Bleeding disorder
- Peritonsillar abscess
- Requiring concomitant uvulopalatopharyngoplasty (UPPP)
- Anticoagulation therapy which cannot be discontinued
- Unable to follow instructions or complete follow-up
- Currently taking any medication known to affect healing
- Currently enrolled in another investigational device or drug trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Surgery Center Merced
Merced, California, 95340
Alvarado Hospital
San Diego, California, 92120
About this study
Official title: A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy
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).
Read the 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).
- Conditions
- Tonsillitis
- Being tested
- PEAK PlasmaBlade TnA, Traditional Electrosurgery with scalpel
- Keywords
- Tonsillectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Medical subject headings
- Tonsillitis, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAK PlasmaBlade TnADevice
Also called PEAK, PlasmaBlade, Plasma Blade, TnA
The PEAK PlasmaBlade will be used for the tonsillectomy.
Traditional Electrosurgery with scalpelDevice
Also called Electrosurgery, Electrocautery, Bovie
Traditional electrosurgery for the tonsillectomy.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Traditional electrosurgery will be used for the tonsillectomy. Receives: Device: Traditional Electrosurgery with scalpel |
| PlasmaBlade | Experimental | The PEAK PlasmaBlade will be used for the tonsillectomy. Receives: Device: PEAK PlasmaBlade TnA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days immediately following surgery
Secondary outcomes (1)
Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level
Measured: 1-2 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012
- Study completionApr 2012
Why it stopped: Termination due to acquisition of PEAK Surgical by Medtronic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Weeks, MD, Principal investigator, Senta ClinicMark Spitzer, DO, Principal investigator, Mark Spitzer, DO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193556
- Sponsor's protocol ID
- PEAK VP-00075
- Acronym
- PRECISE
- Status last verified
- Nov 2012
- First submitted
- 31 Aug 2010
- Last updated
- 3 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy
- ClinicalTrials.gov ID
- NCT01193556
- Acronym / sponsor ID
- PRECISE / PEAK VP-00075
- Conditions
- Tonsillitis
- Keywords
- Tonsillectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination due to acquisition of PEAK Surgical by Medtronic
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Posted 3 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Device: Traditional Electrosurgery with scalpelTraditional electrosurgery will be used for the tonsillectomy. |
| PlasmaBlade | Experimental | Device: PEAK PlasmaBlade TnAThe PEAK PlasmaBlade will be used for the tonsillectomy. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Children \& adolescents: Age 3-17; Adults: 18 and older
- Physically healthy, stable weight
- Requiring tonsillectomy and adenoidectomy per widely accepted indications
- For adults, subject must understand the nature of the procedure and provide written informed consent.
- 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.
Key exclusion criteria (8 listed)
- Children: Age 2 and under
- Bleeding disorder
- Peritonsillar abscess
- Requiring concomitant uvulopalatopharyngoplasty (UPPP)
- Anticoagulation therapy which cannot be discontinued
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAK PlasmaBlade TnAAlso: PEAK, PlasmaBlade, Plasma Blade, TnAThe PEAK PlasmaBlade will be used for the tonsillectomy. | Device | PlasmaBlade |
| Traditional Electrosurgery with scalpelAlso: Electrosurgery, Electrocautery, BovieTraditional electrosurgery for the tonsillectomy. | Device | Standard of Care |
Primary outcome
Post-operative Pain
Time frame: 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.
1 secondary outcome
Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level
Time frame: 1-2 weeks post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Weeks, MD principal investigator
Senta Clinic
Mark Spitzer, DO principal investigator
Mark Spitzer, DO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAK PlasmaBlade TnA and Traditional Electrosurgery with scalpel in people with Tonsillitis, run by Medtronic Surgical Technologies at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain (time frame: 10 days immediately following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.