18 and older, any sex, with Tonsillectomy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 1
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
Group
Value
95% CI
BiZact Arm
5.4
± 2.59
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 2
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
Group
Value
95% CI
BiZact Arm
5.9
± 2.36
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 3
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
Group
Value
95% CI
BiZact Arm
6.1
± 2.05
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 4
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
Group
Value
95% CI
BiZact Arm
6.3
± 2.01
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 5
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
Group
Value
95% CI
BiZact Arm
6.3
± 2.16
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 6
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
Group
Value
95% CI
BiZact Arm
6.0
± 2.25
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 7
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
Group
Value
95% CI
BiZact Arm
4.9
± 2.54
Pain Assessment Using a Visual Analog Scale (VAS)Primary· Post-operative Day 10
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
Group
Value
95% CI
BiZact Arm
2.7
± 2.54
Pain Assessment Using a Visual Analog Scale (VAS)Primary· 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
Group
Value
95% CI
BiZact Arm
1.2
± 1.78
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 ProceduresSecondary· Post-operative Day 28
Ability to return to Normal, subject's baseline, diet. EORTC Quality of Life Questionnaire (EORTC QLQ -H\&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems.
Group
Value
95% CI
BiZact Arm
12.3
± 2.57
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 ProceduresSecondary· Post-operative Day 28
Ability to return to Normal, subject's baseline, activity. EORTC Quality of Life Questionnaire (EORTC QLQ -H\&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more probl
Group
Value
95% CI
BiZact Arm
12.4
± 2.77
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collects from baseline and day 0 to 14 days follow up.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Medtronic - MITG
Last refreshed: 7 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02876575.