A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tonsillectomy
- Sponsor
- Medtronic - MITG
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Pain Assessment Using a Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to assess 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.
Detailed Description
Study Design: Prospective, multi-center, single-arm non-comparative pilot study to assess the severity of post-operative pain with the use of BiZact™ for tonsillectomy. Study Visits: * Screening * Surgery, Day 0 * Post-Op Follow-up Day 1 - Day 7 \& Day 10 (Home assessments) * Post-Op Follow-up Day 14 (Office Visit)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (male or female) ≥22 in United States and ≥18 years of age in Europe years of age
- •Scheduled to undergo tonsillectomy
- •Signed informed consent by subject
Exclusion Criteria
- •Subjects undergoing:
- •Simultaneous adenoidectomy
- •Tonsillectomy as a result of cancer
- •Unilateral tonsillectomy
- •Current participation in other clinical trials
- •Subjects with:
- •Current tobacco use
- •Known bleeding disorders
- •History of peritonsillar abscess
- •Craniofacial disorders
Outcomes
Primary Outcomes
Pain Assessment Using a Visual Analog Scale (VAS)
Time Frame: Post-operative Day 14
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
Secondary Outcomes
- 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(Post-operative Day 28)
- 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(Post-operative Day 28)