NCT01948219

Brief Summary

The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

September 16, 2013

Last Update Submit

April 3, 2018

Conditions

Total Laryngectomy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of device implant procedure

    Number of patients with adverse event associated with device implantation procedure

    1 year

Other Outcomes (5)

  • Quality of life

    1, 3, 6 months and 1 year

  • Number of patients with adverse events

    1 year

  • Dyspnea evolution

    1,2,3,6,9 months and 1 year

  • +2 more other outcomes

Study Arms (1)

ENTegral Artificial Larynx implant

EXPERIMENTAL

ENTegral Artificial Larynx implantation

Device: ENTegral Artificial Larynx implant

Interventions

ENTegral Artificial Larynx implantDEVICE
ENTegral Artificial Larynx implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than or equal to 18 years old
  • Is indicated for total laryngectomy (first intention)
  • Must be able to comply with study requirements
  • Must be able to understand and be willing to provide written informed consent

You may not qualify if:

  • Any condition that precludes the implantation of the ENTegral AL
  • Existing coagulation disorder
  • Contraindication for general anesthesia
  • Tumoral extension outside of the larynx invading through extra-laryngeal structures
  • Previous radiotherapy
  • Life-expectancy \< 12 months
  • Be pregnant of breastfeeding or intention to becoming pregnant during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Mont-Godinne

Yvoir, 5530, Belgium

Location

CHU Strasbourg

Strasbourg, 67000, France

Location

CHU Toulouse

Toulouse, 31000, France

Location

Study Design

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

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 23, 2013

Study Start

October 1, 2014

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

FR(2)BE(1)