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ENT FiberLase CO2 Study

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ClinicalTrials.gov Identifier: NCT01276418
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.

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).

Condition or disease Intervention/treatment Phase
Laryngeal Diseases Pharyngeal Diseases Device: CO2 laser Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ENT FiberLase CO2 Study
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Device: CO2 laser
Ablation and coagulation of soft tissue
Other Names:
  • Acupulse WG CO2 Laser
  • Fiberlase Flexible Fiber




Primary Outcome Measures :
  1. Ability to complete procedure with the study device [ Time Frame: Immediate - during intervention ]
    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

  2. Complications (bleeding, perforation, damage to non target tissue) [ Time Frame: During intervention and up to 6 weeks following the procedure ]
    Number of subjects with Adverse Events as a Measure of Safety



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276418


Locations
Belgium
University Hospital of Mont-Godinne
Yvoir, Belgium, 5530
Italy
Bufalini Hospital
Cesena, Italy
Sponsors and Collaborators
Lumenis Ltd.

Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT01276418     History of Changes
Other Study ID Numbers: LUM-SBUSUR-ACF-09-01
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: January 2012

Additional relevant MeSH terms:
Laryngeal Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Stomatognathic Diseases