Surgical Procedure, UnspecifiedNCT06535555
Safety and Feasibility of ActivSight(tm) in the Identification of The Ureter Via Riboflavin Fluorescence
A study testing Investigational Safety and Feasibility in people with Surgical Procedure, Unspecified, run by Activ Surgical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Investigational Safety and Feasibility
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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 0.5 - 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 510(k) 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 inclusion/exclusion 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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Investigational Safety and Feasibility
- Keywords
- ureter, advanced imaging, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Safety and FeasibilityDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Investigational Safety and Feasibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral visibility
1-5 point scale, surgeon assessment of how visible the ureter was on imaging
Measured: Immediately post-operative
Ease of use
1-5 point scale, surgeon assessment of how easy the technology was to use intraoperatively
Measured: Immediately post-operative
Time required to identify ureter
1-5 point scale, surgeon assessment of how much time it took to identify the ureter
Measured: Immediately post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study startMar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Activ Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535555
- Sponsor's protocol ID
- 600-00012
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31311922Delacroix 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.
PubMed 21629628Andersen 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.
PubMed 25154890Engel 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.
PubMed 26049877Thompson 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.
PubMed 28485121Fernando 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.
PubMed 21472446Stitely 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.
PubMed 30633139
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of ActivSight(tm) in the Identification of The Ureter Via Riboflavin Fluorescence
- ClinicalTrials.gov ID
- NCT06535555
- Acronym / sponsor ID
- 600-00012
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- ureter, advanced imaging, surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Activ SurgicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 0.5 - 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 510(k) 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 inclusion/exclusion 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Device: Investigational Safety and FeasibilityPatients 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- Known or suspected history of any of the following:
- Active malignancy
- Uncontrolled hypertension
- Multiple chronic recurring urinary tract infections (isolated urinary tract infections are acceptable)
- BMI > 35 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Safety and FeasibilityTechnical 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) | Device | Investigational Arm |
Primary outcome
Ureteral visibility
Time frame: Immediately post-operative
1-5 point scale, surgeon assessment of how visible the ureter was on imaging
Ease of use
Time frame: Immediately post-operative
1-5 point scale, surgeon assessment of how easy the technology was to use intraoperatively
Time required to identify ureter
Time frame: Immediately post-operative
1-5 point scale, surgeon assessment of how much time it took to identify the ureter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 31311922de 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.
- Background: PubMed 21629628Delacroix 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.
- Background: PubMed 25154890Andersen 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.
- Background: PubMed 26049877Engel 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.
- Background: PubMed 28485121Thompson 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.
- Background: PubMed 21472446Fernando 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.
- Background: PubMed 30633139Stitely 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Safety and Feasibility in people with Surgical Procedure, Unspecified, run by Activ Surgical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ureteral visibility (time frame: Immediately post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535555, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.