Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure

NCT05879835 · View on ClinicalTrials.gov ↗

Study Summary

A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).

Interventions

  • DEVICE KiteLock 4% Sterile Catheter Lock Solution
  • DEVICE Heparin Lock Solution

Study Locations (8)

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Nationwide Children's Hospital — Columbus

Massachusetts

  • Boston Children's Hospital — Boston

Nebraska

  • University of Nebraska Medical Center — Omaha

New York

  • Columbia University Irving Medical Center — New York

North Carolina

  • Duke University Medical Center — Durham

Texas

  • Cook Children's Health Care System — Fort Worth

Washington

  • Seattle Children's Hospital — Seattle

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2024-06-21
Est. Completion 2026-06
Phase NA

Sponsor

SterileCare

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05879835

The ClinicalTrials.gov registry entry for NCT05879835 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SterileCare, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pediatric Intestinal Failure appearing as the primary indexed condition, and to 2 interventions — of which KiteLock 4% Sterile Catheter Lock Solution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05879835 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Ohio, Massachusetts, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05879835 about?

NCT05879835 is a clinical study titled "KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure". A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).

What is the current status of trial NCT05879835?

This trial is currently recruiting. It is a NA study. The enrollment target is 124 participants. The study started on 2024-06-21. Estimated completion is 2026-06.

What conditions does trial NCT05879835 study?

This clinical trial studies the following conditions: Pediatric Intestinal Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05879835?

The interventions under investigation include: KiteLock 4% Sterile Catheter Lock Solution (DEVICE), Heparin Lock Solution (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05879835?

This trial is sponsored by SterileCare, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05879835 being conducted?

This trial has 8 study locations across Massachusetts, Nebraska, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial