Trials / Completed
CompletedNCT02876575
A Study of BiZact™ on Adults Undergoing Tonsillectomy
A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | A bipolar instrument for tonsillectomies | 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. |
Timeline
- Start date
- 2017-02-13
- Primary completion
- 2018-10-24
- Completion
- 2018-10-24
- First posted
- 2016-08-24
- Last updated
- 2020-04-07
- Results posted
- 2019-12-26
Locations
2 sites across 2 countries: United States, Sweden
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02876575. Inclusion in this directory is not an endorsement.