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COMPLETED Phase 1

Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis

NCT00941317 · View on ClinicalTrials.gov ↗

Study Summary

Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established. However clinical testing is needed to establish optimal drilling conditions to be used for further development in both unaffected and affected parts of the nail. The aim of this study is to determine the optimal drilling condition that could be used in future studies of this device in combination with topical treatment for onychomycosis.

Conditions Studied

Interventions

  • DEVICE Pathformer (micro-drilling device)

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2009-07
Est. Completion 2009-09
Phase Phase 1

Sponsor

Galderma R&D

49 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00941317

The ClinicalTrials.gov registry entry for NCT00941317 describes a study currently listed as completed. It is categorized as Phase 1, 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 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 49 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 Onychomycosis appearing as the primary indexed condition, and to 1 intervention — of which Pathformer (micro-drilling device) 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: NCT00941317 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. 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 NCT00941317 about?

NCT00941317 is a clinical study titled "Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis". Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established. However clinical testing is needed to establish optimal drilling conditions to be used for further development in both unaffected and affecte...

What is the current status of trial NCT00941317?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2009-07. Estimated completion is 2009-09.

What conditions does trial NCT00941317 study?

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

What interventions are being tested in trial NCT00941317?

The interventions under investigation include: Pathformer (micro-drilling device) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00941317?

This trial is sponsored by Galderma R&D, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00941317 being conducted?

This trial has 1 study location across Massachusetts. 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