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ENT FiberLase CO2 Study

Primary Purpose

Laryngeal Diseases, Pharyngeal Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CO2 laser
Sponsored by
Lumenis Be Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngeal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure.
  2. Adult
  3. Able and willing to comply with all visit, treatment and evaluation schedule and requirements
  4. Able to understand and provide written Informed Consent
  5. Disease which requires tissue ablation for treatment

Exclusion Criteria:

  1. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion);
  2. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process
  3. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
  4. Any condition which, in the Physician's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research

Sites / Locations

  • University Hospital of Mont-Godinne
  • Bufalini Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Ability to complete procedure with the study device
The number of interventions that were completed using the AcuPulse WG and FiberLase CO2 Fiber for the intended indication, without the need to revert to other means
Complications (bleeding, perforation, damage to non target tissue)
Number of subjects with Adverse Events as a Measure of Safety

Secondary Outcome Measures

Full Information

First Posted
January 9, 2011
Last Updated
September 6, 2016
Sponsor
Lumenis Be Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01276418
Brief Title
ENT FiberLase CO2 Study
Official Title
ENT FiberLase CO2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumenis Be Ltd.

4. Oversight

5. Study Description

Brief Summary
This study is intended to collect data regarding treatment with a new flexible fiber used to transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study will include a single treatment that is performed transorally (through the mouth) for oral or laryngeal indications in the field of Ear, Nose and Throate (ENT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Diseases, Pharyngeal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CO2 laser
Other Intervention Name(s)
Acupulse WG CO2 Laser, Fiberlase Flexible Fiber
Intervention Description
Ablation and coagulation of soft tissue
Primary Outcome Measure Information:
Title
Ability to complete procedure with the study device
Description
The number of interventions that were completed using the AcuPulse WG and FiberLase CO2 Fiber for the intended indication, without the need to revert to other means
Time Frame
Immediate - during intervention
Title
Complications (bleeding, perforation, damage to non target tissue)
Description
Number of subjects with Adverse Events as a Measure of Safety
Time Frame
During intervention and up to 6 weeks following the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure. Adult Able and willing to comply with all visit, treatment and evaluation schedule and requirements Able to understand and provide written Informed Consent Disease which requires tissue ablation for treatment Exclusion Criteria: Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion); Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process Mentally incompetent, prisoner or evidence of active substance or alcohol abuse; Any condition which, in the Physician's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research
Facility Information:
Facility Name
University Hospital of Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Bufalini Hospital
City
Cesena
Country
Italy

12. IPD Sharing Statement

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ENT FiberLase CO2 Study

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