Trial · NCT02604264

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

NCT02604264, Not applicable, Completed, Pursuit Vascular, Inc.; results first posted 2017-05-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap. Trials, record NCT02604264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02604264

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
NCT number: NCT02604264
Status: Completed
Phases: Not applicable
Enrollment: 2,912 participants, actual
Lead sponsor: Pursuit Vascular, Inc.
Conditions: End Stage Renal Disease (ESRD)
Interventions: ClearGuard HD end cap
First posted: 2015-11-13
Last updated: 2018-09-11
Results first posted: 2017-05-01
Limitations and caveats: This was a pragmatic post market study. There was an informed consent waiver and no CRF's. Treatment arm adverse events during the 12-month intervention period were monitored using the FDA MAUDE database and none were reported.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days	Up to 12 months	This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows. The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days	Up to 12 months		PBCs per 1,000 CVC-days	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days	Treatment		0.26		PBCs per 1,000 CVC-days
Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days	Control		0.59		PBCs per 1,000 CVC-days

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run-In	STARTED	Treatment	618
Run-In	STARTED	Control	611
Run-In	COMPLETED	Treatment	618
Run-In	COMPLETED	Control	611
Run-In	NOT COMPLETED	Treatment	0
Run-In	NOT COMPLETED	Control	0
Intervention	STARTED	Treatment	1,445
Intervention	STARTED	Control	1,467
Intervention	COMPLETED	Treatment	1,245
Intervention	COMPLETED	Control	1,225

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment	134	1,245
Total, all-cause mortality	Control	127	1,225
Total, other adverse events	Treatment	0	1,245
Total, other adverse events	Control	0	1,225
Total, serious adverse events	Treatment	0	1,245
Total, serious adverse events	Control	0	1,225

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27839894	RESULT	PubMed
35363884	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Treatment vs Control: deaths from any cause	Trial comparisons
Treatment vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02604264

GET https://conductscience.org/api/trials/v1/NCT02604264/registered

API reference For AI assistants