Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap

Pursuit Vascular

Status: Completed

Conditions: End Stage Renal Disease (ESRD)

Treatments: Device: ClearGuard HD End Cap

Study type: Interventional

Funder types: Industry

Identifiers

NCT02593149

CLP-0002

Details and patient eligibility

About

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.

Full description

Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.

Enrollment: 1,902 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients dialyzing with a central venous catheter

Exclusion criteria

• Known allergy to chlorhexidine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,902 participants in 2 patient groups

Treatment

Experimental group

Description:

ClearGuard HD End Cap

Treatment:

Device: ClearGuard HD End Cap

Control

No Intervention group

Description:

Tego® connector with the CurosTM for Tego disinfecting port protector