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RECRUITING Phase 2

AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

NCT04263025 · View on ClinicalTrials.gov ↗

Study Summary

This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.

Conditions Studied

Interventions

  • BIOLOGICAL Cryopreserved Umbilical Cord Allograft
  • PROCEDURE Robot-Assisted Radical Prostatectomy

Study Locations (1)

New Jersey

  • Hackensack University Medical Center — Hackensack

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2020-01-30
Est. Completion 2027-04-01
Phase Phase 2

Sponsor

Hackensack Meridian Health

57 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04263025

The ClinicalTrials.gov registry entry for NCT04263025 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hackensack Meridian Health, which has 57 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 Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which Cryopreserved Umbilical Cord Allograft 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: NCT04263025 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. 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 NCT04263025 about?

NCT04263025 is a clinical study titled "AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft". This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinar...

What is the current status of trial NCT04263025?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2020-01-30. Estimated completion is 2027-04-01.

What conditions does trial NCT04263025 study?

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

What interventions are being tested in trial NCT04263025?

The interventions under investigation include: Cryopreserved Umbilical Cord Allograft (BIOLOGICAL), Robot-Assisted Radical Prostatectomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04263025?

This trial is sponsored by Hackensack Meridian Health, which has 57 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04263025 being conducted?

This trial has 1 study location across New Jersey. 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