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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roux-en-Y gastric bypass patients with weight regain | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Napoleon | Device | The Micro-Tech Endoscopic Measurement Device named Napoleon is a small catheter with a 30mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA. The device was originally intended to measure polyps. However, it is used off-label in this study and is considered investigational. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device | 8 months | |
| Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition | 8 months |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. History of prior endoscopies with complications
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Bellevue Hospital Center |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Violeta.Popov@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
Requests may be directed to: Violeta.Popov@nyulangone.org.
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|
| Visual estimation | Other | For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. |
|
| Additional procedure time needed to incorporate use of Napoleon | 8 months |
| Proportion of cases with adverse events or unanticipated problems related to use of Napoleon | 8 months |
| New York |
| New York |
| 10016 |
| United States |