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NCT01107795 · ClinicalTrials.gov registry record
Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS
A clinical trial, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- 41
- Enrollment target
NCT01107795: Clinical Trial study, sponsored by University of Alabama at Birmingham.
NCT01107795 is a clinical trial that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01107795 was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- 41 participants
- Enrollment target
Study Summary
This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only and does not provide for evaluations or treatment of OSAHS.
Primary Outcome
Improvement in Apnea Hypopnea Index (AHI) score, as measured by a polysomnogram sleep study. The AHI score is the number of apnea events per hour, with a lower score indicating mild sleep apnea and a higher score indicating severe sleep apnea. An improved AHI score would be a lower score at 6 months than at 3 months and baseline.
Interventions
- PROCEDURE Transoral Robotic Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-03-04 |
| Est. Completion | 2019-07-26 |
Why NCT01107795 stopped before completion
NCT01107795 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 41 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Transoral Robotic Surgery is the first listed.
NCT01107795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01107795 about?
NCT01107795 is a clinical study titled "Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS". This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only and does not provide for...
What is the current status of trial NCT01107795?
This trial is currently terminated. The enrollment target is 41 participants. The study started on 2010-03-04. Estimated completion is 2019-07-26.
What interventions are being tested in trial NCT01107795?
The interventions under investigation include: Transoral Robotic Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01107795?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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