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RECRUITING NA

NobleStitch EL STITCH Trial is a PFO Comparative Trial

NCT04339699 · View on ClinicalTrials.gov ↗

Study Summary

STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.

Interventions

  • DEVICE NobleStitch™EL Suture Mediated Closure System
  • DEVICE Amplatzer PFO Occluder

Study Locations (2)

Arizona

  • TMC HealthCare — Tucson

Lazio

  • Ospedale S. Eugenio — Rome

Trial Details

FieldValue
Enrollment Target 640 participants
Start Date 2021-01-01
Est. Completion 2027-06-30
Phase NA

Sponsor

Nobles Medical Technologies II

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04339699

The ClinicalTrials.gov registry entry for NCT04339699 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 640 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nobles Medical Technologies II, 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 2 conditions, with Stroke, Ischemic appearing as the primary indexed condition, and to 2 interventions — of which NobleStitch™EL Suture Mediated Closure System 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: NCT04339699 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Arizona, Lazio. 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 NCT04339699 about?

NCT04339699 is a clinical study titled "NobleStitch EL STITCH Trial is a PFO Comparative Trial". STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.

What is the current status of trial NCT04339699?

This trial is currently recruiting. It is a NA study. The enrollment target is 640 participants. The study started on 2021-01-01. Estimated completion is 2027-06-30.

What conditions does trial NCT04339699 study?

This clinical trial studies the following conditions: Stroke, Ischemic, Foramen Ovale, Patent. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04339699?

The interventions under investigation include: NobleStitch™EL Suture Mediated Closure System (DEVICE), Amplatzer PFO Occluder (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04339699?

This trial is sponsored by Nobles Medical Technologies II, 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 NCT04339699 being conducted?

This trial has 2 study locations across Arizona, Lazio. 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