Gastric BypassNCT04832282
Napoleon Measurement of Gastrojejunal Anastomosis
A study testing Napoleon and Visual estimation in people with Gastric Bypass and Weight Regain, run by NYU Langone Health at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Bypass, Weight Regain
- What is being tested?
- Napoleon and Visual estimation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2021to 1 Dec 2026
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- RYGB patient with weight regain age 18-90
- Scheduled for an endoscopy
- Willingness and ability to provide informed consent
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. History of prior endoscopies with complications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Bellevue Hospital Center
New York, New York, 10016
About this study
Official title: Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
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.
- Conditions
- Gastric Bypass, Weight Regain
- Being tested
- Napoleon, Visual estimation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapoleonDevice
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.
Visual estimationOther
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Napoleon; Other: Visual estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
Measured: 8 months
Secondary outcomes (4)
Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device
Measured: 8 months
Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition
Measured: 8 months
Additional procedure time needed to incorporate use of Napoleon
Measured: 8 months
Proportion of cases with adverse events or unanticipated problems related to use of Napoleon
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start14 Jun 2021
- Primary completion30 Jun 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric BypassStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832282
- Sponsor's protocol ID
- 20-01436
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2021
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
- ClinicalTrials.gov ID
- NCT04832282
- Acronym / sponsor ID
- 20-01436
- Conditions
- Gastric Bypass, Weight Regain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Apr 2021 (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 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass patients with weight regain | Other | Device: Napoleon, Other: Visual estimationThe 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 may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- RYGB patient with weight regain age 18-90
- Scheduled for an endoscopy
- Willingness and ability to provide informed consent
Key exclusion criteria (2 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. History of prior endoscopies with complications
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 |
|---|---|---|
| NapoleonThe 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. | Device | Roux-en-Y gastric bypass patients with weight regain |
| Visual estimationFor each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. | Other | Roux-en-Y gastric bypass patients with weight regain |
Primary outcome
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
Time frame: 8 months
4 secondary outcomes
Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device
Time frame: 8 months
Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition
Time frame: 8 months
Additional procedure time needed to incorporate use of Napoleon
Time frame: 8 months
Proportion of cases with adverse events or unanticipated problems related to use of Napoleon
Time frame: 8 months
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Napoleon and Visual estimation in people with Gastric Bypass and Weight Regain, run by NYU Langone Health at 2 sites in United States.
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 4 inclusion and 2 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation (time frame: 8 months). 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 2 Nov 2026.