ENT FiberLase CO2 Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Lumenis Ltd..
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
First received: January 9, 2011
Last updated: January 15, 2012
Last verified: January 2012
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).
Device: CO2 laser
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||ENT FiberLase CO2 Study
Primary Outcome Measures:
- Ability to complete procedure with the study device [ Time Frame: Immediate - during intervention ] [ Designated as safety issue: No ]
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) [ Time Frame: During intervention and up to 6 weeks following the procedure ] [ Designated as safety issue: Yes ]
Number of subjects with Adverse Events as a Measure of Safety
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
Device: CO2 laser
Ablation and coagulation of soft tissue
- Acupulse WG CO2 Laser
- Fiberlase Flexible Fiber
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276418
|University Hospital of Mont-Godinne
|5530 , Yvoir, Belgium |
|Cesena, Italy |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 9, 2011
||January 15, 2012
||Belgium: Federal Agency for Medicines and Health Products, FAMHP
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 20, 2014
Respiratory Tract Diseases