ENTegral Artificial Larynx Clinical Trial

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Status Terminated

Clinical Trial Summary

The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms