Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535555
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2023-02-10
Brief Title:
Safety and Feasibility of ActivSighttm in the Identification of The Ureter Via Riboflavin Fluorescence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Feasibility of ActivSighttm in the Identification of The Ureter Via Riboflavin Fluorescence
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Was never initiated
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 clinical need for real-time identification of the ureter during laparoscopic abdominal surgery Iatrogenic ureteral injury is amongst the most feared complications of lower abdominal surgery with incidence varying from 05 - 1 in cancer surgery to as high as 10 in gynecologic oncologic surgery 2-5 Ureters are thin-walled and at risk for injury as they are poorly distinguished from surrounding retroperitoneal tissue and are usually in a collapsed state Unrecognized ureteral damage during surgery can lead to long-term morbidity including kidney failure In their publication this team proposes the use of a zwitterionic near-infrared fluorophore that could be detected in real-time via near-infrared fluorescence imaging Activ Surgical has developed and commercialized ActivSight a near-infrared fluorescence detector that combines an innovative form factor and proprietary software to deliver precise objective cost efficient real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery A small adaptor fits between any existing laparoscope and camera system and a separate light source is placed along any current commercial system to deliver objective real-time tissue perfusion and blood flow information intraoperatively ActivSight received 510k clearance from the US FDA in 2020 According to its labelling ActivSight is intended to provide real-time endoscopic fluorescence and near infrared imaging ActivSight enables surgeons to visually assess blood flow and related tissue perfusion using fluorescence and near infrared imaging and at least one of the major bile ducts cystic duct common bile duct or common hepatic duct using fluorescence all during minimally invasive surgery In this clinical feasibility study Activ Surgical proposes a slightly different approach from the above-referenced publication to achieve real-time ureter identification during elective laparoscopic abdominal surgery Instead of utilizing a zwitterionic fluorophore to fluoresce the ureter Activ Surgical is investigating a common over-the-counter water-soluble vitamin riboflavin also known as vitamin B2
While typically administered as a dietary supplement the medical literature contains many large studies of riboflavin use as prophylaxis for migraines 6 It has also been studied and used to identify ureteral jets during cystoscopy as a method of confirming ureter patency after pelvic prolapse surgery 7-8
Riboflavin possesses properties of fluorescence with three strong areas of fluorescence 9 in the visible wavelength spectrum To detect the fluorescence of riboflavin changes were made to ActivSight hardware for this study these changes are detailed herein 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 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 Subjects presenting for elective laparoscopic abdominopelvic surgery meeting the inclusionexclusion criteria detailed below will be consented and asked to permit the surgeons to identify their ureter with the prototype ActivSight system during elective laparoscopic surgery after ingesting the proper dosage of riboflavin pre-surgery Video of the ureter examination will be recorded and analyzed post-surgery retained video will be devoid of any protected health information
While typically administered as a dietary supplement the medical literature contains many large studies of riboflavin use as prophylaxis for migraines 6 It has also been studied and used to identify ureteral jets during cystoscopy as a method of confirming ureter patency after pelvic prolapse surgery 7-8
Riboflavin possesses properties of fluorescence with three strong areas of fluorescence 9 in the visible wavelength spectrum To detect the fluorescence of riboflavin changes were made to ActivSight hardware for this study these changes are detailed herein 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 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 Subjects presenting for elective laparoscopic abdominopelvic surgery meeting the inclusionexclusion criteria detailed below will be consented and asked to permit the surgeons to identify their ureter with the prototype ActivSight system during elective laparoscopic surgery after ingesting the proper dosage of riboflavin pre-surgery Video of the ureter examination will be recorded and analyzed post-surgery retained video will be devoid of any protected health information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None