Dynamic Laryngotracheal Separation for Aspiration | NCT00580346

Studies
Dynamic Laryngotracheal Separation for Aspiration

NCT00580346

Sponsor

University Hospitals Cleveland Medical Center

Status

Withdrawn

Last Update Posted

Jul 21, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Aspiration Pneumonia

Interventions

Placement of laryngeal implant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Dec 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2022

Last Update Posted Date

Jul 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Experimental		Device: Placement of laryngeal implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placement of laryngeal implant	Device	Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Videotaping vocal cords and modified barium swallows		several months

Secondary Outcomes

Measure	Description	Time Frame
Tolerance of implanted device		immediate to several years
comfort in swallowing		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Broniatowski, MD	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Health System		Cleveland	Ohio	44106	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11801992	Background	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. doi: 10.1097/00005537-200111000-00031.

ID	Term
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases

ID	Type	Description	Link
NIH DC-006703-01
IDE G980179