Napoleon Measurement for Gastric Bypass Evaluation

Recruiting at 1 trial location

Overseen By Sandy Ng, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: NYU Langone Health

Disqualifiers: Prior endoscopy complications

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Napoleon Measurement for Gastric Bypass Evaluation safe for humans?

The available research on gastric bypass procedures generally indicates they are safe, with low rates of serious complications and mortality. However, specific safety data for the Napoleon Measurement or similar devices is not provided in the available studies. ^{1 2 3 4 5}

How does the Napoleon Measurement for Gastric Bypass Evaluation treatment differ from other treatments for obesity surgery?

The Napoleon Measurement for Gastric Bypass Evaluation is unique because it involves a precise method for measuring the size of the gastric outlet after obesity surgery using a fiberoptic endoscope and a Fogarty catheter. This method is more accurate and reproducible compared to traditional endoscopic estimation, which helps in better assessing and managing post-surgical outcomes. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for Roux-en-Y gastric bypass patients aged 18-90 who have experienced weight regain and are scheduled for an endoscopy. They must be willing to consent to the study. Those with a history of complications from prior endoscopies cannot participate.

Inclusion Criteria

I had gastric bypass surgery and have gained weight back.

I am willing and able to give my consent for treatment.

I am scheduled for an endoscopy.

Exclusion Criteria

I have had complications from previous endoscopies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Endoscopy and Measurement

Participants undergo endoscopy where the gastrojejunal anastomosis (GJA) is visually estimated and measured using the Napoleon device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedural effects and the ease of use of the Napoleon device is assessed through a survey

1-2 weeks

Treatment Details

Interventions

• Napoleon

Trial Overview The Napoleon device's ability to measure the size of gastrojejunal anastomosis in gastric bypass patients is being tested against traditional visual estimation by doctors during endoscopy procedures at two hospitals.

Participant Groups

Group I: Roux-en-Y gastric bypass patients with weight regain Experimental Treatment 2 Interventions

The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Findings from Research

A modified one-anastomosis gastric bypass was developed for patients with grade 1 and 2 obesity, demonstrating high safety and effectiveness, with all 16 patients achieving a normal BMI within 6 months post-surgery.

The procedure allows for postoperative gastrointestinal examinations without the risk of intestinal malabsorption, making it a reversible option for weight loss surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[One-anastomosis gastric bypass with a short limb]. Evdoshenko, VV., Fedenko, VV., Bordan, NS., et al.[2022]

A review of FDA data from January 2017 to November 2020 identified 773 cases involving intragastric balloons, revealing a total of 1134 patient complications, primarily due to device leaks (33.4%).

The most common adverse events reported were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%), indicating significant side effects that need to be managed to enhance the effectiveness of this obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. Ramai, D., Bhandari, P., Facciorusso, A., et al.[2021]

The gastric bypass procedure was found to be safe and effective, with a low operative mortality rate of 1% and significant complications in only 10% of the 210 morbidly obese patients studied, all of whom were followed up.

Patients experienced substantial weight loss, averaging a reduction from 289 pounds to 176 pounds at 18 months post-surgery, with over 95% maintaining this weight loss during a 36-month observation period, and notable health improvements in conditions like diabetes and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Greenville gastric bypass. Progress report at 3 years. Flickinger, EG., Pories, WJ., Meelheim, HD., et al.[2019]

In a study of 235 patients who underwent jejunoiliac bypass for obesity, the operative lethality was 2.1% and 21% experienced postoperative complications, with significant late complications such as liver damage in 15% and electrolyte deficits in 12%.

Among 1585 patients who had various stomach-bypass procedures, the overall postoperative lethality was lower at 1.6%, and 90% reported high satisfaction with the results, while only 5% experienced weight gain after 5 years, indicating the effectiveness of these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jejunoileal bypass versus gastric bypass or gastroplasty in the operative treatment of obesity. Scott, HW.[2019]

Diet and exercise alone have not proven effective for sustained weight loss in most obese individuals, while surgical interventions can lead to prolonged weight loss but may result in rebound weight gain over time.

The authors propose a new framework for evaluating medical devices aimed at treating obesity, focusing on a benefit-risk assessment to guide the development and approval of these devices, which was discussed at an FDA workshop and advisory panel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. Lerner, H., Whang, J., Nipper, R.[2021]

A new method using a fiberoptic endoscope and a Fogarty catheter was developed to accurately measure the gastric outlet size after obesity surgery, proving to be more reliable than traditional endoscopic estimation methods.

The study demonstrated high reproducibility of measurements, indicating that different examiners can achieve consistent results, which is crucial for monitoring post-surgery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method for measuring the size of the gastric outlet in obesity surgery. Näslund, I.[2008]

Bariatric surgery in France has evolved significantly over 15 years, with adjustable gastric banding and gastric bypass being the most common procedures, each associated with different types of complications.

Gastric bypass tends to have more serious early postoperative complications, while adjustable gastric banding is prone to long-term surgical and mechanical issues, highlighting the importance of long-term follow-up and coordination by general practitioners to manage potential late complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term management of patients after bariatric surgery]. Coupaye, M., Ledoux, S., Msika, S.[2016]

Using a calibration balloon tube for sizing the pouch and channel during gastroplasty can significantly reduce the time and complications associated with the traditional manometer method, enhancing the safety of the procedure.

This technique effectively addresses three major issues in gastric stapling surgery: ensuring the pouch is appropriately sized, the channel is correctly sized, and preventing postoperative leaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Calibration Balloon Tube to Size the Pouch and Channel in Gastroplasty Procedures. Pingree, JH., Jack, JE.[2019]

In a study involving 18 patients undergoing gastric banding, objective measurements of the upper pouch size revealed that surgeons' subjective estimates were significantly smaller than the actual size, indicating a potential risk for inadequate weight loss outcomes.

The findings emphasize the importance of using standardized objective measurements for upper pouch size in gastric surgeries to ensure better evaluation of surgical effectiveness and patient weight loss results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between subjective and objective estimates of upper pouch volume at gastric banding for obesity. Granström, L., Backman, L.[2006]

The study validated a new guidewire for measuring gastric outlet diameters in patients who have undergone Roux-en-Y gastric bypass, showing high interobserver agreement with an intra-class correlation coefficient of 0.83, similar to the gold standard measurement tool.

Both expert endoscopists and trainees achieved reliable measurements with the new guidewire, indicating that it can be effectively used by practitioners at different skill levels, which may enhance the assessment of patients at risk of weight regain after bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a new method for the endoscopic measurement of post-bariatric gastric outlet using a standard guidewire: an observer agreement study. de Quadros, LG., Galvão Neto, MD., Campos, JM., et al.[2019]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[One-anastomosis gastric bypass with a short limb]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Greenville gastric bypass. Progress report at 3 years. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Jejunoileal bypass versus gastric bypass or gastroplasty in the operative treatment of obesity. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. [2021]

6. Sweden pubmed.ncbi.nlm.nih.gov

A method for measuring the size of the gastric outlet in obesity surgery. [2008]

7. France pubmed.ncbi.nlm.nih.gov

[Long-term management of patients after bariatric surgery]. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Use of a Calibration Balloon Tube to Size the Pouch and Channel in Gastroplasty Procedures. [2019]

9. Sweden pubmed.ncbi.nlm.nih.gov

Comparison between subjective and objective estimates of upper pouch volume at gastric banding for obesity. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Validation of a new method for the endoscopic measurement of post-bariatric gastric outlet using a standard guidewire: an observer agreement study. [2019]