Status:
WITHDRAWN
Safety and Feasibility of ActivSight(tm) in the Identification of The Ureter Via Riboflavin Fluorescence
Lead Sponsor:
Activ Surgical
Conditions:
Surgical Procedure, Unspecified
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief 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...
Detailed Description
In the 2019 publication, "A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery," by de Valk, et al. \[1\], the authors present the cl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06535555
Start Date
March 1 2023
End Date
December 1 2023
Last Update
August 2 2024
Active Locations (1)
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1
Center for Special Surgery
Roswell, Georgia, United States, 30076