Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07385430 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of LGW16-03 To Identify Nerves

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date changed from estimate of Jun 15, 2026 to Jul 8, 2026v5
  2. Recruitment opened
    • Start date: May 1, 2026 to Jun 15, 2026
    • Site details revised
    v4
  3. Start date: Feb 1, 2026 to May 1, 2026v3
  4. Eligibility criteria expanded, about 28 wordsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants undergoing open-field orthopaedic surgery. Secondary goals include: 1) identifying the lowest dose without adverse events that provides peak florescence imaging contrast, and 2) characterizing the pharmacokinetics of LGW16-03. Participants will receive a one-time intravenous infusion of the investigational drug (LGW16-03) prior to their planned surgery. Participants' vitals will be closely monitored and will have blood samples taken at regular intervals. Fluorescence images of their major nerve will be taken during surgery. Participants will have one study follow-up visit approximately 30 days after their surgery.
Trial Details
NCT Number NCT07385430
Lead Sponsor Eric R. Henderson
Collaborators: Oregon Health and Science University, National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Adults, Open-field Surgery, Major Nerve
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov