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NCT02116608 · ClinicalTrials.gov registry record · Phase 4

Treatment of Tracheostomy Granulomas

A Phase 4 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
26
Enrollment target

NCT02116608: Completed Phase 4 study, sponsored by University of Colorado, Denver.

NCT02116608 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02116608, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
26 participants
Enrollment target

Study Summary

This study plans to learn more about the different ways used to treat tracheostomy granulomas. Investigators want to see which standard of care method (steroid application, silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.

Primary Outcome

Definition of success: The investigators are defining successful treatment of tracheostomy granulomas as a decrease in the frequency of granulomas over a six week observation period using the assigned treatment or partial or complete resolution of the granuloma. Partial resolution is defined as 25-75% resolution and complete resolution is defined as greater than 75% resolution. Definition of failure: The investigators are defining a treatment as a failure if during the six week observation peri

Interventions

  • DRUG Betadine
  • DRUG Silver Nitrate
  • DRUG Hydrocortisone Butyrate Cream, 1.0%

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2014-09
Est. Completion 2019-09-05
Phase Phase 4
University of Colorado, Denver

1,283 total trials

What the finished NCT02116608 record still lists

NCT02116608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which Betadine is the first listed.

NCT02116608 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02116608 about?

NCT02116608 is a clinical study titled "Treatment of Tracheostomy Granulomas". This study plans to learn more about the different ways used to treat tracheostomy granulomas. Investigators want to see which standard of care method (steroid application, silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.

What is the current status of trial NCT02116608?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2014-09. Estimated completion is 2019-09-05.

What interventions are being tested in trial NCT02116608?

The interventions under investigation include: Betadine (DRUG), Silver Nitrate (DRUG), Hydrocortisone Butyrate Cream, 1.0% (DRUG).

Who is sponsoring clinical trial NCT02116608?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02116608's enrollment target sits among peer trials

26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02116608, the US trial registry maintained by the National Library of Medicine. NCT02116608 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.