ENT FiberLase CO2 Study

Pharyngeal Diseases Clinical Trial

Official title:

ENT FiberLase CO2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276418
• Other study ID #: LUM-SBUSUR-ACF-09-01
• Status: Completed
• Phase: N/A
• First received: January 9, 2011
• Last updated: September 6, 2016
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2012
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngeal Diseases
• Pharyngeal Diseases

Intervention

Device:
• CO2 laser
Ablation and coagulation of soft tissue

Locations

Country	Name	City	State
Belgium	University Hospital of Mont-Godinne	Yvoir
Italy	Bufalini Hospital	Cesena

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes