Napoleon Measurement for Gastric Bypass Evaluation
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: NYU Langone Health
Disqualifiers: Prior endoscopy complications
No Placebo Group
Approved in 1 Jurisdiction
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?
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.678910
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.
Trial 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 (Measurement Device)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Roux-en-Y gastric bypass patients with weight regainExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
Bellevue Hospital CenterNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
Brigham and Women's HospitalCollaborator
References
[One-anastomosis gastric bypass with a short limb]. [2022]To develop an acceptable method of surgical treatment of patients with obesity grade 1 and 2 in accordance with the following criteria: high safety, no risk or minimal risk of intestinal malabsorption, no limitations for postoperative gastrointestinal examination, no need for organ resection and surgical reversibility in case of necessity.
Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. [2021]Intragastric balloons have been used to bridge the obesity treatment gap. We aim to investigate the number and type of complications associated with intragastric balloons using public-access governmental databanks. We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2017 through Nov 2020. During the study period, approximately 773 cases with 830 device issues and 1134 patient complications were identified. Most balloon complications were due to leaks (33.4%). The most reported adverse events were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%). Findings from the MAUDE database highlight patient and device adverse outcomes that should be addressed to improve clinical success.
The Greenville gastric bypass. Progress report at 3 years. [2019]Two hundred and ten morbidly obese patients underwent a standardized gastric bypass procedure between February 1980 and November 1983. We conclude, based on 100% follow-up, that the operation is safe (operative mortality--1%, significant complications--10%) and effective (reoperation rate--4%). Only one patient failed to lose more than 25% of preoperative weight. The operation produced a mean weight loss in the group from 289 pounds (202-505) before surgery to 176 pounds (118-308) at 18 months after surgery. Stated as "per cent of ideal weight," patients lost from a preoperative mean of 214% (153-350) to 130% (88-189) at 18 months. Maximum weight loss was reached by 18 months after the procedure and was maintained during 36 months of observation in over 95% of patients. When patients were divided into four groups according to preoperative weight, weight loss occurred at a roughly similar rate, but heavier patients, although they lost more weight, plateaued at a higher weight than patients originally less obese. Striking and objective benefits were seen in patients with diabetes, hypertension, heart disease, and pulmonary insufficiency.
Jejunoileal bypass versus gastric bypass or gastroplasty in the operative treatment of obesity. [2019]A comparative study has been made of three methods for the operative treatment of obesity. Of my own cases, 235 underwent a jejunoiliac bypass procedure, and the results have been analyzed: operative lethality 2.1%; postoperative complications 21%. Of the patients whose residual ileum was quite short (about 45 cm), about 70% reached their ideal weight. Metabolic late complications were considerable (e.g., liver damage in 15%, electrolyte deficit in 12%, and arthritis in 10%). In the late observation time of 14 years, 14 patients died, 10 of them as a result of the operation. Three different stomach-bypass procedures are described. The collective statistics compiled on 1585 patients indicated 1.6% postoperative lethality and 22% postoperative complications. Of the total patients. 90% were very satisfied with the procedure and in only 5% was a weight gain recorded after 5 years. The latest procedure is gastroplasty according to the Gomez method: the first 200 cases show 0.5% postoperative lethality and postoperative complications in 18.5%. Although this procedure is technically simple, the late observation time is not yet adequate for a definitive comparison.
Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. [2021]Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012.
A method for measuring the size of the gastric outlet in obesity surgery. [2008]A simple method was evolved for measuring the gastric outlet size following surgery for obesity. Measurements are made through a fiberoptic endoscope, using a Fogarty catheter. A "phantom" study showed the method to be accurate and superior to endoscopic estimation without a reference balloon. High interexaminer and intraexaminer reproducibility was confirmed by independent measurements in patients.
[Long-term management of patients after bariatric surgery]. [2016]Bariatric surgery has developed substantially in France over the past 15 years. It has numerous complications that vary according to the type of procedure. Adjustable gastric banding and gastric bypass are the most common bariatric surgery techniques in France. The adjustable gastric band is particularly subject to surgical and mechanical complications long after surgery. Early postoperative complications are more frequent after gastric bypass and generally more serious than with the gastric band. Longer after surgery, the gastric bypass has essentially nutritional complications. The role of the general practitioner is fundamental in coordinating follow-up of patients, in collaboration with the medical-surgical team that performed the operation. Long-term follow-up of patients is essential because of the risk of late complications.
Use of a Calibration Balloon Tube to Size the Pouch and Channel in Gastroplasty Procedures. [2019]Gastroplasty is currently one of the most common surgical procedures performed on the morbidly obese for weight loss. An adequate result can be assured only if the pouch that is created is less than 30 ml and the channel that connects that pouch to the distal stomach is approximately 1 cm in diameter. The current method to size the pouch is to occlude the esophagus and the outlet of the pouch and to measure with a manometer through a naso-gastric tube. We contend this method is both time consuming and adds to the potential of complications. Through the use of a calibration balloon tube the size of the pouch can be quickly and safely estimated. It can also be used to size the channel between the pouch and the distal stomach and check for leaks. The technique of how this tube has been used over the past 6 years is described. By the use of a calibration balloon tube, three problem areas in gastric stapling surgery for morbid obesity are avoided, namely: inappropriate pouch size, inappropriate channel size and postoperative leaks.
Comparison between subjective and objective estimates of upper pouch volume at gastric banding for obesity. [2006]Small size of the upper pouch has been considered mandatory for good weight loss after different gastric operations for extreme obesity. In most published series the estimates of upper pouch size seem to have been subjective. The present report concerns gastric banding in 18 patients, with standardized objective measurement of the upper pouch made after subjective estimation independently by two bariatrically trained surgeons. The subjective determination resulted in statistically significant underestimation compared with the objective procedure. For adequate evaluation of the surgical method, therefore, it is important to measure the pouch size objectively.
Validation of a new method for the endoscopic measurement of post-bariatric gastric outlet using a standard guidewire: an observer agreement study. [2019]Between 10 and 20% of all patients undergoing bariatric surgery procedures regain weight secondary to a gastrojejunostomy enlargement. The aim of this study was to validate the interobserver agreement while measuring gastric outlet diameters using a new standard guidewire.