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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A bipolar instrument for tonsillectomies | Other | A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A bipolar instrument for tonsillectomies | Device | A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 1 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 2 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 3 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups:
|
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Inclusion Criteria:
Exclusion Criteria:
Subjects undergoing:
Subjects with:
The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
The subject has participated in any drug or device research study within 30 days of enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Ron Karni, MD | University of Texas at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health | Houston | Texas | 77030 | United States | ||
| Sophia Hemmet |
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A total of 48 Adults, greater than or equal to 22 in the US and greater than or equal to 18 in Europe, were enrolled into a single-arm trial. A total of 50 subjects were screened and consented and 2 subjects were withdrawn due to physician request.
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| ID | Title | Description |
|---|---|---|
| FG000 | BiZact Arm | A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adults (male or female) ≥22 years of age in United States and
≥18 years of age in Europe 2. Scheduled to undergo tonsillectomy 3. Signed informed consent by subject
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| ID | Title | Description |
|---|---|---|
| BG000 | BiZact Arm | 48 adults undergoing tonsillectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 1 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 1 |
|
Adverse Events were collects from baseline and day 0 to 14 days follow up
In alignment with ISO 14155:2011 (Section 3.2), an Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device and the procedures involved.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BiZact Arm | 48 adults undergoing tonsillectomy | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Tonsillectomy Hemorrhage | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melody LaBeau, Director of Clinical Operations | Medtronic | 7635262931 | melody.a.labeau@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2018 | Nov 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Post-operative Day 4 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 5 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 6 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 7 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 10 |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| Post-operative Day 14 |
| 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 | 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 problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups:
| Post-operative Day 28 |
| Stockholm |
| Sweden |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Undergoing Tonsillectomy | Count of Participants | Participants |
|
| Signed Informed Consent | Count of Participants | Participants |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 2 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 2 |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 45 out of 48 subjects completed the post-operative assessment as directed by the protocol, 3 subjects did not completed the assessment on day 3 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 3 |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 4 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 4 |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 5 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 5 |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 6 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 6 |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 7 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 7 |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 10 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 10 |
|
|
|
| Primary | Pain Assessment Using a Visual Analog Scale (VAS) | 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:
| 46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 14 as directed by the protocol. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 14 |
|
|
|
| Secondary | 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 | 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. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups:
| Posted | Mean | Standard Deviation | days | Post-operative Day 28 |
|
|
|
| Secondary | 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 | 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 problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups:
| Posted | Mean | Standard Deviation | days | Post-operative Day 28 |
|
|
|
| 48 |
| 0 |
| 48 |
| 6 |
| 48 |
| Pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
Medical Center /Investigator may publish the results of work performed under this Agreement, in accordance with the Publication Policy described in the Clinical Investigation Plan and publication guidelines from the Declaration of Helsinki; provided, however, that any such Publication shall be at a time determined by Medtronic and shall be provided to Medtronic for review at least sixty (60) days prior to submission or presentation.