Back to resultsENT FiberLase CO2 Study
Primary Purpose
Laryngeal Diseases, Pharyngeal Diseases
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CO2 laser
Sponsored by
About this trial
This is an interventional treatment trial for Laryngeal Diseases
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
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
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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