What is the mechanism of action of this treatment?

Common treatments for obesity include bariatric surgery and pharmacological interventions. Bariatric surgery, such as Roux-en-Y gastric bypass, works by altering the gastrointestinal tract to reduce food intake and nutrient absorption, leading to significant weight loss and improvement in obesity-related conditions. Pharmacological treatments often target appetite regulation, fat absorption, or metabolic rate. The use of Near-Infrared Fluorescence (NIF) Imaging in bariatric surgery ensures proper blood flow to the surgical site, reducing complications like leaks and strictures, which is crucial for patient recovery and long-term success.

What side effects are associated with this type of intervention?

Common treatments for obesity, such as Roux-en-Y gastric bypass and sleeve gastrectomy, can have several side effects. These include early complications like bleeding, infections, and anastomotic leaks, as well as longer-term issues such as nutritional deficiencies, dumping syndrome, and gastrointestinal symptoms like nausea and vomiting. Additionally, patients may experience marginal ulcers, strictures, and weight regain over time. It is crucial for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity, including surgical interventions like Roux-en-Y gastric bypass surgery, which is a focus of the NIF Imaging trial. This surgery is designed to reduce the size of the stomach and reroute the intestines, leading to significant weight loss. Additionally, the FDA has approved various pharmacological treatments for obesity, such as orlistat, phentermine-topiramate, and liraglutide, which aid in weight loss through different mechanisms. These treatments, both surgical and pharmacological, provide multiple options for managing obesity.

What other types of research exist?

Promising alternatives to NIF Imaging for assessing anastomotic blood flow in obesity patients include: 1) Acoustic Radiation Force Impulse (ARFI) Elastography, which uses ultrasound to measure tissue stiffness and can help assess blood flow and tissue viability. 2) Shear-Wave Elastography (SWE), another ultrasound-based technique that provides real-time imaging of tissue stiffness and can be used intraoperatively. 3) Indocyanine Green (ICG) Angiography, which, although similar to NIF, uses different wavelengths and can be combined with other imaging modalities for enhanced visualization. These methods offer non-invasive, real-time assessment of tissue perfusion and viability, making them suitable for intraoperative use in bariatric surgery.

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Indocyanine Green Imaging for Bariatric Surgery

Phase 4

Recruiting

Led By Allan Okrainec

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial uses a special imaging technique with a dye to help doctors see blood flow during gastric bypass surgery. It aims to reduce complications like ulcers and leaks by ensuring good blood flow at surgical connections. The study focuses on patients having this type of weight-loss surgery.

Who is the study for?

This trial is for adults over 18 who are eligible for Roux-en-Y gastric bypass (RYGB) surgery in Ontario and can commit to the bariatric program's follow-up, including lifestyle changes. They must be able to consent and may have had treatment for a marginal ulcer. It excludes those with allergies to indocyanine green or Sodium Iodide, substance abuse/smoking issues, unwillingness to take PPIs post-op, pregnancy plans within two years, or bleeding/coagulation disorders.

What is being tested?

The study tests if using the Stryker 1688 AIM system along with Indocyanine Green dye helps surgeons see blood flow during RYGB surgery better. The goal is to check if this method reduces complications like ulcers, leaks, and strictures after surgery.

What are the potential side effects?

Potential side effects include allergic reactions to Indocyanine Green such as itching or rash; however specific side effects related directly from its use in this surgical context will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.

Secondary study objectives

The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).

To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Interventional group (with drug)Experimental Treatment2 Interventions

The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine green

2016

Completed Phase 4

~1720

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include bariatric surgery and pharmacological interventions. Bariatric surgery, such as Roux-en-Y gastric bypass, works by altering the gastrointestinal tract to reduce food intake and nutrient absorption, leading to significant weight loss and improvement in obesity-related conditions. Pharmacological treatments often target appetite regulation, fat absorption, or metabolic rate. The use of Near-Infrared Fluorescence (NIF) Imaging in bariatric surgery ensures proper blood flow to the surgical site, reducing complications like leaks and strictures, which is crucial for patient recovery and long-term success.

The Feasibility of Examining the Effects of Gastric Bypass Surgery on Intestinal Metabolism: Prospective, Longitudinal Mechanistic Clinical Trial.