← Back to Search

Investigational Arm for Surgical Procedure

N/A
Waitlist Available
Research Sponsored by Activ Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days post-op
Awards & highlights

Summary

The main Objective of this study is to determine the safety and feasibility of a prototype ActivSightTM in identifying the ureter in real-time during elective laparoscopic abdominopelvic surgery after pre-surgical administration of riboflavin. This study seeks to identify the ureter only; ActivSight™ will not be used to Safety and Feasibility of ActivSightTM in the Identification of the Ureter via Riboflavin Fluorescence guide treatment or the surgical procedure. As such, this is a non-significant risk study. Riboflavin is a common dietary supplement and will be administered at dosages shown previously to be well-tolerated for migraine prophylaxis \[6\]. ActivSight™ is an imaging system connected to the standard laparoscopic system already existing in the OR at the site. Changes made to the commercial ActivSight™ hardware for this study introduce no significant risk

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ease of use
Time required to identify ureter
Ureteral visibility
Other study objectives
Adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Investigational ArmExperimental Treatment1 Intervention
Patients in the investigational arm will ingest 400mg PO riboflavin pre-operatively. At the start of their procedure, after the surgeon gain laparoscopic access using their standard procedures and equipment, the updated version of the ActivSight device will be placed through a standard laparoscopic trocar and attempts will be made to visualize the ureter under direct imaging using light in the visible spectrum. When the surgeon is complete with the attempted visualization, they will remove the ActivSight device and proceed with their normal operative course and equipment. No surgical decisions will be made based upon this information, and the device will only be used during the aforementioned time.

Find a Location

Who is running the clinical trial?

Activ SurgicalLead Sponsor
3 Previous Clinical Trials
257 Total Patients Enrolled
~0 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top