ENT FiberLase CO2 Study

Lumenis

Status: Completed

Conditions: Laryngeal Diseases; Pharyngeal Diseases

Treatments: Device: CO2 laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01276418

LUM-SBUSUR-ACF-09-01

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: CO2 laser