Ulcer, GastricPhase 4NCT06002906
The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.
A Phase 4 study testing Indocyanine green and Stryker 1688 AIM system in people with Ulcer, Gastric and Obesity, Morbid, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Gastric, Obesity, Morbid
- What is being tested?
- Indocyanine green and Stryker 1688 AIM system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2023to 3 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capacity to provide informed consent.
- Over the Age of 18.
- Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB surgery by the bariatric program.
- Commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss.
- Treatment of marginal ulcer with the revisional surgery.
Who cannot join
- Not willing to participate in study
- Contraindication to, or not planned to undergo RYGB
- Known allergy to indocyanine green or Sodium Iodide
- Is participant pregnant or planning to get pregnant in next two years
- Ongoing substance abuse or active smoking
- Bleeding diathesis or Coagulopathy
- Unwilling to take PPI medication Post operatively
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T2S8
About this study
Official title: The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.
Read the detailed description
The purpose of this study is to examine intraoperative usefulness of near-infrared light fluorescence imaging with a contrast agent called indocyanine green to improve visualization of blood flow to a surgical connection between the small intestine and stomach (gastrojejunostomy) in patients undergoing gastric bypass surgery. ICG will be given prior to and after making the gastrojejunostomy to examine blood flow and then a subjective perfusion score will be given by the surgeon and assistant during the surgery.
Patients will be recruited before the laparoscopic Roux-en-Y gastric bypass surgery and the study data will be collected prospectively through standard bariatric follow up visits up to 2 years. A mid-term analysis of the procedure and patient outcomes will be performed for quality assurance purposes when half the study patients have undergone intraoperative ICG use. The ICG will be not given if a patient is allergic to sodium iodide or has a history of allergy to iodides because of the risk of a severe allergic reaction.
Participants will be assigned an identifying number to protect confidentiality. Descriptive univariate and multivariate statistical analysis will be performed on all patients satisfying the study's inclusion criteria.
- Conditions
- Ulcer, Gastric, Obesity, Morbid
- Being tested
- Indocyanine green, Stryker 1688 AIM system
- Medical subject headings
- Stomach Ulcer, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called SPY AGENT GREEN
Indocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion.
Stryker 1688 AIM systemDevice
The Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group (with drug) | Experimental | The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy. Receives: Drug: Indocyanine green; Device: Stryker 1688 AIM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
ICG imaging will be performed intraoperatively using an existing imaging system (1688 Advanced Imaging Modalities (AIM) System (Stryker)), and the images will be assessed by the operating surgeons and as well as by an independent surgeon (part of the study team, independent from the surgery) postoperatively using a subjective assessment of intraoperative Fluorescence Intensity (FI), a 5-point scale to check blood flow of the stomach and small intestine at the new connection. The scale range is 1 to 5 where a score of 1 signifies no fluorescence signal and poor blood supply whereas a score of 5 signifies maximum fluorescence signal and blood supply. Images will also be analyzed postoperatively to obtain an objective score based on fluorescence intensity. The applicability of ICG imaging in the context of RYGB will be assessed based on the inter-observer agreement.
Measured: 2 years
Secondary outcomes (2)
The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).
The patients in the Toronto Western Hospital as per the standard care of bariatric program will be followed for up to 2 years following surgery to identify any complications including marginal ulcerations. Data is collected prospectively at the study site. The investigator will also use the data from the 5-point scale scoring system reference above to determine the correlation between the scores and the occurrence of marginal ulcers and any other complications (leaks, strictures).
Measured: 2 years
To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.
Based on the literature, the investigator does not anticipate intra-operative or injection-related adverse effects. Nevertheless, the investigator will use the existing database that collects postoperative outcomes for 30 days to identify adverse events, if any.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Jan 2023
- Primary completion3 Jul 2027 (estimated)
- Study completion3 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer, GastricStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Endoscopy
- Responsible party
- Principal investigator, Allan Okrainec, University Health Network, Toronto
- Investigators
- Allan Okrainec, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002906
- Sponsor's protocol ID
- 20-5008
- Status last verified
- Oct 2025
- First submitted
- 9 Aug 2023
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06002906
- Acronym / sponsor ID
- 20-5008
- Conditions
- Ulcer, Gastric, Obesity, Morbid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Stryker Endoscopy
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 3 Jul 2027 (estimated)
- Study completion
- 3 Jul 2027 (estimated)
- First posted
- 21 Aug 2023 (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.
This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.
Detailed description
The purpose of this study is to examine intraoperative usefulness of near-infrared light fluorescence imaging with a contrast agent called indocyanine green to improve visualization of blood flow to a surgical connection between the small intestine and stomach (gastrojejunostomy) in patients undergoing gastric bypass surgery. ICG will be given prior to and after making the gastrojejunostomy to examine blood flow and then a subjective perfusion score will be given by the surgeon and assistant during the surgery.
Patients will be recruited before the laparoscopic Roux-en-Y gastric bypass surgery and the study data will be collected prospectively through standard bariatric follow up visits up to 2 years. A mid-term analysis of the procedure and patient outcomes will be performed for quality assurance purposes when half the study patients have undergone intraoperative ICG use. The ICG will be not given if a patient is allergic to sodium iodide or has a history of allergy to iodides because of the risk of a severe allergic reaction.
Participants will be assigned an identifying number to protect confidentiality. Descriptive univariate and multivariate statistical analysis will be performed on all patients satisfying the study's inclusion criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group (with drug) | Experimental | Drug: Indocyanine green, Device: Stryker 1688 AIM systemThe interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capacity to provide informed consent.
- Over the Age of 18.
- Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB surgery by the bariatric program.
- Commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss.
- Treatment of marginal ulcer with the revisional surgery.
Key exclusion criteria (7 listed)
- Not willing to participate in study
- Contraindication to, or not planned to undergo RYGB
- Known allergy to indocyanine green or Sodium Iodide
- Is participant pregnant or planning to get pregnant in next two years
- Ongoing substance abuse or active smoking
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 |
|---|---|---|
| Indocyanine greenAlso: SPY AGENT GREENIndocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion. | Drug | Interventional group (with drug) |
| Stryker 1688 AIM systemThe Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography. | Device | Interventional group (with drug) |
Primary outcome
The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
Time frame: 2 years
ICG imaging will be performed intraoperatively using an existing imaging system (1688 Advanced Imaging Modalities (AIM) System (Stryker)), and the images will be assessed by the operating surgeons and as well as by an independent surgeon (part of the study team, independent from the surgery) postoperatively using a subjective assessment of intraoperative Fluorescence Intensity (FI), a 5-point scale to check blood flow of the stomach and small intestine at the new connection. The scale range is 1 to 5 where a score of 1 signifies no fluorescence signal and poor blood supply whereas a score of 5 signifies maximum fluorescence signal and blood supply. Images will also be analyzed postoperatively to obtain an objective score based on fluorescence intensity. The applicability of ICG imaging in the context of RYGB will be assessed based on the inter-observer agreement.
2 secondary outcomes
The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).
Time frame: 2 years
To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- 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.
Allan Okrainec principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine green and Stryker 1688 AIM system in people with Ulcer, Gastric and Obesity, Morbid, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2025. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2025.