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Completed

NCT Number: NCT01276418

ENT FiberLase CO2 Study

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).

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Key information

Conditions

Laryngeal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Mont-Godinne, Yvoir, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CO2 laser

Device

Ablation and coagulation of soft tissue

Other names: Acupulse WG CO2 Laser, Fiberlase Flexible Fiber

Primary outcomes

  1. Ability to complete procedure with the study device

    Time frame: Immediate - during intervention

    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

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

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

    Number of subjects with Adverse Events as a Measure of Safety

Sponsors and collaborators

Lead sponsor

Lumenis Be Ltd.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 13, 2011
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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