Trials / Completed
CompletedNCT02593149
Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,902 (actual)
- Sponsor
- Pursuit Vascular, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.
Detailed description
Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ClearGuard HD End Cap | The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2015-10-30
- Last updated
- 2019-02-27
- Results posted
- 2019-02-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02593149. Inclusion in this directory is not an endorsement.