Intra-laryngeal Implant for Treatment of Chronic Aspirations

NCT03325725 | Withdrawn

• 1 other identifier: NB_LD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.

Conditions

Aspiration Pneumonia; Tracheostomy Complication

Keywords

severe aspiration

Outcome Measures

Primary Outcomes (1)

• Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)

  Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)

  7 days

Other Outcomes (2)

• Stability of the NewBreez LD: Number of patients who kept the implant until the end of the study period.

  30 days

• Safety of the NewBreez LD: Number of patient with adverse events will be assessed at each follow-up during the study period

  2, 7, 30 days

Study Arms (1)

NewBreez LD Intra-laryngeal implant

EXPERIMENTAL

Device: NewBreez LD intra-laryngeal implant

Interventions

NewBreez LD intra-laryngeal implant DEVICE

NewBreez LD intra-laryngeal implantation

NewBreez LD Intra-laryngeal implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Swallowing disorders characterized by chronic aspirations;
• Tracheotomy performed, inter alia, in the management of swallowing disorders;
• Aged over 18;
• Willing and able to comply with the requirements of the study;
• Informed consent signed;
• Affiliated patient or beneficiary of the social security system.

You may not qualify if:

• Do not implant in patients with incomplete cricoid cartilage (surgery or other);
• Do not implant in patients with tracheotomy performed by cricothyroidectomy or between cricoid cartilage and the 1st tracheal ring;
• Do not implant in patients with tracheal lumen in the 1st tracheal ring, the lateral and anteroposterior diameters of which are less than 11 mm;
• Do not implant in patients with tight trismus;
• Do not implant in subjects less than 18 years of age;
• Do not implant in patients with bleeding disorders;
• Do not implant in patients contraindicated to general anesthesia.

Sponsors & Collaborators

• ProTiP Medical: lead

Study Sites (2)

CHU Strasbourg

Strasbourg, 67000, France

Location

CHU Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christian Debry, Pr.

  CHU Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 30, 2017
• Study Start: January 9, 2018
• Primary Completion: January 9, 2018
• Study Completion: January 9, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

FR (2)