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
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.
ClinicalTrials.gov Identifier:
NCT01276418
First received: January 9, 2011
Last updated: January 15, 2012
Last verified: January 2012
  Purpose

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 Intervention
Laryngeal Diseases
Pharyngeal Diseases
Device: CO2 laser

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ENT FiberLase CO2 Study

Resource links provided by NLM:


Further study details as provided by Lumenis Ltd.:

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: 50
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: CO2 laser
Ablation and coagulation of soft tissue
Other Names:
  • Acupulse WG CO2 Laser
  • Fiberlase Flexible Fiber

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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

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

No publications provided

Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT01276418     History of Changes
Other Study ID Numbers: LUM-SBUSUR-ACF-09-01
Study First Received: January 9, 2011
Last Updated: January 15, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on September 18, 2014