ENT FiberLase CO2 Study

Lumenis Be Ltd.49 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Laryngeal Diseases Pharyngeal Diseases

Interventions

CO2 laserDEVICE

Ablation and coagulation of soft tissue

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital of Mont-Godinne

Yvoir, Belgium

Bufalini Hospital

Cesena, Italy

Outcomes

Primary Outcomes

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

Time frame: Immediate - during intervention

Complications (bleeding, perforation, damage to non target tissue)

Number of subjects with Adverse Events as a Measure of Safety

Time frame: During intervention and up to 6 weeks following the procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.