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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 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.
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)?
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01815554
The ClinicalTrials.gov registry entry for NCT01815554 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (64% lower). The listed sponsor is Craig Hospital, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 0 interventions.
NCT01815554 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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