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NCT01815554 · ClinicalTrials.gov registry record
Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia
A clinical trial of Spinal Cord Injury and Tetraplegia, sponsored by Craig Hospital.
- Completed
- Registry status
- 31
- Enrollment target
- 1
- Study location
NCT01815554: Completed study of Spinal Cord Injury and Tetraplegia, sponsored by Craig Hospital.
NCT01815554 is a study of Spinal Cord Injury and Tetraplegia that has completed, run by Craig Hospital. The registered enrollment target is 31 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815554, a study of Spinal Cord Injury and Tetraplegia, has completed, sponsored by Craig Hospital.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an observational longitudinal study designed to identify and describe long term outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As this is not a randomized or experimental study, no specific hypotheses are proposed. The data collected will enable us to answer the following research questions: 1. What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS stimulus parameters, abandonment of DPS and related reasons). 2. What mechanical problems have DPS users encountered (system failure, repairs needed)? 3. What are the frequency of and reasons for rehospitalization following DPS implant? 4. What levels of care are needed at home to manage the DPS? 5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste, swallowing)?
Primary Outcome
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Conditions Studied
Study Locations (1)
Colorado
- Craig Hospital - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-04 |
What the finished NCT01815554 record still lists
NCT01815554 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 0 interventions.
NCT01815554 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01815554 about?
NCT01815554 is a clinical study titled "Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia". This is an observational longitudinal study designed to identify and describe long term outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As this is not a randomized or experimental study, no specific hypotheses are proposed. The data collected will enable us t...
What is the current status of trial NCT01815554?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2013-01. Estimated completion is 2016-04.
What conditions does trial NCT01815554 study?
This clinical trial studies the following conditions: Spinal Cord Injury, Tetraplegia.
Who is sponsoring clinical trial NCT01815554?
This trial is sponsored by Craig Hospital, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01815554 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01815554's enrollment target sits among peer trials
31 45th of 99 higher than 55 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury 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.
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