Safety and Feasibility of ActivSight(tm) in the Identification of The Ureter Via Riboflavin Fluorescence
Withdrawn before enrolling · Not applicable
Conditions studied: Surgical Procedure, Unspecified
In brief
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
Key facts
- Study ID
- NCT06535555
- Run by
- Activ Surgical
- People needed
- 0
- Starts
- 2023-03-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2024-08-02
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ages 22 to 65 presenting for elective laparoscopic abdominopelvic surgery
- No contraindication to riboflavin and able to ingest riboflavin in pill form
- Willing and able to consent to the study
- Native language is English or proficient in both written and spoken English
You may not qualify if…
- Known or suspected history of any of the following:
- Kidney or liver disease
- Vitamin deficiency or transporter deficiency or metabolic disorder
- Pelvic surgery (including gynecologic, colorectal, urologic, etc.)
- Pelvic radiation
- Abdominopelvic trauma
- Ureteral injury or presence of ureteral stent(s)
- Bladder injury
- Kidney stones
- Inflammatory bowel disease
- Neurologic disorder, including seizure or stroke history (history of migraine is acceptable)
- Any form of diabetes
- Active malignancy
- Uncontrolled hypertension
- Multiple chronic recurring urinary tract infections (isolated urinary tract infections are acceptable)
- BMI > 35 kg/m2
- Pregnant or lactating
Where it is running
- Center for Special Surgery — Roswell, Georgia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.