Safety and Feasibility of ActivSight(tm) in the Identification of The Ureter Via Riboflavin Fluorescence

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Surgical Procedure, Unspecified
Interventions
DEVICE

Investigational Safety and Feasibility

"Technical feasibility will be assessed based on a five-point rating scale assessing the ease-of-use, ureteral visibility, and time required to identify the ureter using ActivSight™. All images and video of the ureter will be recorded, but surgeon feedback will be used to assess technical success based on a five point scale, rather than these (subsequently de-identified) recordings.~Safety will be confirmed through clinical assessments and evaluation of adverse events intraoperatively and through a 28-day follow-up period using the criteria listed below. All adverse events will be adjudicated by the site's Principal Investigator (PI) to judge the relatedness of the adverse event to either the administration of riboflavin or the use of the prototype ActivSight™ device (or whether the adverse event was unrelated to either)"

Trial Locations (1)

30076

Center for Special Surgery, Roswell

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Activ Surgical

INDUSTRY