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NCT04455035 · ClinicalTrials.gov registry record · NA
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT04455035: Clinical Trial NA study, sponsored by The University of Texas Health Science Center, Houston.
NCT04455035 is a NA study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04455035, a NA study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.
Primary Outcome
Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.
Interventions
- OTHER Comparator: Retrospective Group(Control)
- DEVICE Prospective Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2021-04-06 |
| Phase | NA |
Why NCT04455035 stopped before completion
NCT04455035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Comparator: Retrospective Group(Control) is the first listed.
NCT04455035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04455035 about?
NCT04455035 is a clinical study titled "DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants". The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.
What is the current status of trial NCT04455035?
This trial is currently terminated. It is a NA study. The enrollment target is 24 participants. The study started on 2020-09-21. Estimated completion is 2021-04-06.
What interventions are being tested in trial NCT04455035?
The interventions under investigation include: Comparator: Retrospective Group(Control) (OTHER), Prospective Group (DEVICE).
Who is sponsoring clinical trial NCT04455035?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04455035's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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