ENT FiberLase CO2 Study

NCT01276418 | Completed

• 1 other identifier: LUM-SBUSUR-ACF-09-01
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

  Immediate - during intervention

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

  Number of subjects with Adverse Events as a Measure of Safety

  During intervention and up to 6 weeks following the procedure

Study Arms (1)

Treatment

EXPERIMENTAL

Device: CO2 laser

Interventions

CO2 laser DEVICE

Ablation and coagulation of soft tissue

Also known as: Acupulse WG CO2 Laser, Fiberlase Flexible Fiber

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure.
• Adult
• Able and willing to comply with all visit, treatment and evaluation schedule and requirements
• Able to understand and provide written Informed Consent
• Disease which requires tissue ablation for treatment

You may not qualify if:

• 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);
• 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
• Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
• 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

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (2)

University Hospital of Mont-Godinne

Yvoir, 5530, Belgium

Location

Bufalini Hospital

Cesena, Italy

Location

MeSH Terms

Conditions

Laryngeal Diseases; Pharyngeal Diseases

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2011
• First Posted: January 13, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 7, 2016

Record last verified: 2012-01

Locations

BE (1); IT (1)