Imagin Medical Inc. (IMEXF)

[jb1965]

Looks like IRB is approved and study is registered

https://clinicaltrials.gov/ct2/show/NCT03058705

Based on this recently added clinical trial study, it looks like the IRB is either approved or almost approved and the study is registered. Start date is April 1, 2017 or about 1 month away. I doubt it will take until March 2018 to complete a 10 patient study.

Near Infrared Fluorescence Imaging for Bladder Cancer Detection
Sponsor: Edward Messing
Collaborator: Imagin Medical
Estimated Enrollment: 10
Anticipated Study Start Date: March 1, 2017
Estimated Study Completion Date: April 1, 2018
Estimated Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)

Experimental: Cysview with Near Infrared Fluorescence (NIRF)
During the transurethral resection of the bladder procedure, the bladder will initially be examined in a systematic meridian fashion. Suspicious tumors identified by white light only, NIRF only, and both will be identified. If intense fluorescence is observed in the initial patient(s) at 10 min, dwell duration will be reduced to 5 min for the next patient(s); if abundant fluorescence is detected there as well, dwell duration will be shortened again to 2.5 min. At least three patients will be studied at each duration to document intense fluorescence before proceeding to shorter instillation durations in subsequent patients.

Drug: Cysview
Intravesical instillation of 100 mg Cysview (hexaminolevulinate hydrochloride) will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Cysview has a favorable safety profile at this dose.
Device: Near Infrared Fluorescence (NIRF)
NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate (Cysview™).

JB