Study Stopped
Termination due to acquisition of PEAK Surgical by Medtronic
PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
PRECISE
A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy
1 other identifier
interventional
51
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
January 3, 2013
CompletedJanuary 3, 2013
November 1, 2012
1.7 years
August 31, 2010
November 29, 2012
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
10 days immediately following surgery
Secondary Outcomes (1)
Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level
1-2 weeks post-operatively
Study Arms (2)
Standard of Care
ACTIVE COMPARATORTraditional electrosurgery will be used for the tonsillectomy.
PlasmaBlade
EXPERIMENTALThe PEAK PlasmaBlade will be used for the tonsillectomy.
Interventions
The PEAK PlasmaBlade will be used for the tonsillectomy.
Traditional electrosurgery for the tonsillectomy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Surgery Center Merced
Merced, California, 95340, United States
Alvarado Hospital
San Diego, California, 92120, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.
Results Point of Contact
- Title
- Robert Swain, PhD
- Organization
- Medtronic Surgical Technologies
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Weeks, MD
Senta Clinic
- PRINCIPAL INVESTIGATOR
Mark Spitzer, DO
Mark Spitzer, DO
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 2, 2010
Study Start
July 1, 2010
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
January 3, 2013
Results First Posted
January 3, 2013
Record last verified: 2012-11