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

NCT06535555 | Withdrawn FDA Device

• 1 other identifier: 600-00012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Keywords

ureter, advanced imaging, surgery

Outcome Measures

Primary Outcomes (3)

• Ureteral visibility

  1-5 point scale, surgeon assessment of how visible the ureter was on imaging

  Immediately post-operative

• Ease of use

  1-5 point scale, surgeon assessment of how easy the technology was to use intraoperatively

  Immediately post-operative

• Time required to identify ureter

  1-5 point scale, surgeon assessment of how much time it took to identify the ureter

  Immediately post-operative

Other Outcomes (1)

• Adverse events

  28 days post-op

Study Arms (1)

Investigational Arm

EXPERIMENTAL

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.

Device: Investigational Safety and Feasibility

Interventions

Investigational Safety and Feasibility DEVICE

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)

Investigational Arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Activ Surgical: lead

Study Sites (1)

Center for Special Surgery

Roswell, Georgia, 30076, United States

Location

Related Publications (7)

• de Valk KS, Handgraaf HJ, Deken MM, Sibinga Mulder BG, Valentijn AR, Terwisscha van Scheltinga AG, Kuil J, van Esdonk MJ, Vuijk J, Bevers RF, Peeters KC, Holman FA, Frangioni JV, Burggraaf J, Vahrmeijer AL. A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery. Nat Commun. 2019 Jul 16;10(1):3118. doi: 10.1038/s41467-019-11014-1.

  PMID: 31311922 BACKGROUND

• Delacroix SE Jr, Winters JC. Urinary tract injures: recognition and management. Clin Colon Rectal Surg. 2010 Jun;23(2):104-12. doi: 10.1055/s-0030-1254297.

  PMID: 21629628 BACKGROUND

• Andersen P, Andersen LM, Iversen LH. Iatrogenic ureteral injury in colorectal cancer surgery: a nationwide study comparing laparoscopic and open approaches. Surg Endosc. 2015 Jun;29(6):1406-12. doi: 10.1007/s00464-014-3814-1. Epub 2014 Aug 26.

  PMID: 25154890 BACKGROUND

• Engel O, Rink M, Fisch M. Management of iatrogenic ureteral injury and techniques for ureteral reconstruction. Curr Opin Urol. 2015 Jul;25(4):331-5. doi: 10.1097/MOU.0000000000000175.

  PMID: 26049877 BACKGROUND

• Thompson DF, Saluja HS. Prophylaxis of migraine headaches with riboflavin: A systematic review. J Clin Pharm Ther. 2017 Aug;42(4):394-403. doi: 10.1111/jcpt.12548. Epub 2017 May 8.

  PMID: 28485121 BACKGROUND

• Fernando S, Dowling C, Rosamilia A. The role of preoperative oral vitamin B in the cystoscopic assessment of ureteric patency. Int Urogynecol J. 2011 Aug;22(8):947-51. doi: 10.1007/s00192-011-1396-1. Epub 2011 Apr 7.

  PMID: 21472446 BACKGROUND

• Stitely ML, Harlow K, MacKenzie E. Oral Riboflavin to Assess Ureteral Patency During Cystoscopy: A Randomized Clinical Trial. Obstet Gynecol. 2019 Feb;133(2):301-307. doi: 10.1097/AOG.0000000000003063.

  PMID: 30633139 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: August 2, 2024
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)