ENTegral Artificial Larynx Clinical Trial | NCT01948219

Studies
ENTegral Artificial Larynx Clinical Trial

NCT01948219

Sponsor

ProTiP Medical

Status

Terminated

Last Update Posted

Apr 5, 2018Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Total Laryngectomy

Interventions

ENTegral Artificial Larynx implant

Countries

Belgium
France

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of recruitment

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Jun 30, 2016Actual

First Submitted Date

Sep 16, 2013

First Submission Date that Met QC Criteria

Sep 18, 2013

First Posted Date

Sep 23, 2013Estimated

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

Apr 3, 2018

Last Update Posted Date

Apr 5, 2018Actual

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

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.

Detailed Description

Not provided

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

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ENTegral Artificial Larynx implant	Experimental	ENTegral Artificial Larynx implantation	Device: ENTegral Artificial Larynx implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENTegral Artificial Larynx implant	Device		ENTegral Artificial Larynx implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of device implant procedure	Number of patients with adverse event associated with device implantation procedure	1 year

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Quality of life	Quality of life using EORTC QLQ-C30 and QLQ-H&N25 questionnaires	1, 3, 6 months and 1 year
Number of patients with adverse events	Number of patients with adverse events will be assessed at each follow-up during the 1 year patient follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Mont-Godinne		Yvoir		5530	Belgium
CHU Strasbourg