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Sponsored by: |
University Hospitals of Cleveland |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00580346 |
People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.
Condition | Intervention | Phase |
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Aspiration Pneumonia |
Device: Placement of laryngeal implant |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double Blind (Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator |
Estimated Enrollment: | 3 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental |
Device: Placement of laryngeal implant
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
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Data pending
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
University Hospitals Health System | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Michael Broniatowski, MD | University Hospitals of Cleveland |
Responsible Party: | University Hospitals of Cleveland health System ( Michael Broniatowski, MD ) |
Study ID Numbers: | 01-01-02, NIH DC-006703-01, IDE G980179 |
Study First Received: | December 21, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00580346 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Aspiration pneumonia Implanted laryngeal stimulator Vocal cord closure Modified barium swallow |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Pneumonia, Aspiration Pneumonia |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Pneumonia, Aspiration Pneumonia |