Trials / Completed
CompletedNCT03487250
Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System
Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 29 (actual)
- Sponsor
- HydroCision, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
Detailed description
This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TenJet System | Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System |
Timeline
- Start date
- 2016-08-04
- Primary completion
- 2019-04-20
- Completion
- 2019-04-20
- First posted
- 2018-04-03
- Last updated
- 2019-04-30
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03487250. Inclusion in this directory is not an endorsement.