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

NCT06535555 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-02

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Activ Surgical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535555 on ClinicalTrials.gov