Clinical Trial Search

Primary: Cumulative Number of Combined Unique Active Lesions — 0.23; 0.02; 3.84; 3.08 lesions

Primary: Progression-free Survival (PFS) — 4.4; 4.4; 4.6 months — p=0.45

Primary: Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24 — 2; 1; 2; 1 participants

Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale

Primary: Spherical Equivalent Refractive Error — -0.386; -0.185; -0.679; -0.548 diopter (D)

Primary: Whole Mouth Mean Modified Gingival Index (MGI) at Week 3 — 2.004; 1.770; 1.807 units on a scale — p=<0.001

Primary: Number of Participants With DLTs — 3 participants

Primary: Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT — 14.30; 13.82; 11.53; 4.80 ng/mL

Primary: Progression-free Survival — 1.8; 0.9 Months

Primary: Successful Procedure Completion — 70; 5 participants

Primary: Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal. — -21.81…

Primary: Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death — 3; 3; 4; 3 participants

Primary: Red Blood Cell (RBC) 24-Hour Recovery — 82.51; 91.70 % 24-hour RBC Recovery

Primary: Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment) — -2.87 units on a scale

Primary: Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR) — 22.81; 8.93 percentage of participants — p=0.0388