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Dynamic Laryngotracheal Separation for Aspiration

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ClinicalTrials.gov Identifier: NCT00580346
Recruitment Status : Suspended (Protocol currently reviewed for updating)
First Posted : December 24, 2007
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE December 24, 2007
Last Update Posted Date February 18, 2009
Study Start Date  ICMJE August 2004
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Videotaping vocal cords and modified barium swallows [ Time Frame: several months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
  • Tolerance of implanted device [ Time Frame: immediate to several years ]
  • comfort in swallowing [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Tolerance of implanted device [ Time Frame: immediate to several years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dynamic Laryngotracheal Separation for Aspiration
Official Title  ICMJE Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
Brief Summary 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.
Detailed Description Data pending
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Aspiration Pneumonia
Intervention  ICMJE Device: Placement of laryngeal implant
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
Other Names:
  • Modified Finetech Vocare Bladder stimulator
  • Huntington perineural electrodes
Study Arms  ICMJE Experimental: 2
Intervention: Device: Placement of laryngeal implant
Publications * Broniatowski M, Grundfest-Broniatowski S, Tyler DJ, Scolieri P, Abbass F, Tucker HM, Brodsky S. Dynamic laryngotracheal closure for aspiration: a preliminary report. Laryngoscope. 2001 Nov;111(11 Pt 1):2032-40.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
3
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2009
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aspiration pneumonia after neurological insults (e.g. stroke)
  • Ability to understand the purpose of the research
  • Appropriate hand motor control
  • Inability to improve under standard treatments (speech-language pathologists)
  • Acceptance of a tracheostomy

Exclusion Criteria:

  • Lack of understanding the research
  • Poor hand motor coordination
  • Uncontrolled seizures
  • Pregnancy
  • Refusal to accept a tracheostomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580346
Other Study ID Numbers  ICMJE 01-01-02
NIH DC-006703-01
IDE G980179
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Broniatowski, MD, University Hospitals of Cleveland health System
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Broniatowski, MD University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP