ENT FiberLase CO2 Study

NCT ID: NCT01276418

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-03-31

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).

Conditions

Laryngeal Diseases; Pharyngeal Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

CO2 laser

Intervention Type: DEVICE

Ablation and coagulation of soft tissue

Interventions

CO2 laser

Ablation and coagulation of soft tissue

Intervention Type: DEVICE

Other Intervention Names

Acupulse WG CO2 Laser; Fiberlase Flexible Fiber

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Mont-Godinne

Yvoir, , Belgium

Bufalini Hospital

Cesena, , Italy

Countries

Belgium; Italy

Other Identifiers

LUM-SBUSUR-ACF-09-01

Identifier Type: -

Identifier Source: org_study_id