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Napoleon Measurement for Gastric Bypass Evaluation

Q: Is my profile compatible with the criteria for this experiment?

This medical trial requires 100 patients aged 18 to 90 who have undergone bypass or gastric surgery, and meet the additional criteria of being scheduled for an endoscopy, as well as possessing the capacity and willingness to provide informed consent.

Q: Is the current research trial open to individuals younger than 85 years old?

As stipulated in the entrance requirements, participants must be 18 or older but cannot exceed 90 years of age.

Q: Does this medical trial still have open slots for participants?

According to information on clinicaltrials.gov, this research study is currently accepting candidates into its program. It was originally posted in June 2021 and last modified in May 2022.

Q: What is the cap on patient enrollment in this clinical trial?

Affirmative. According to clinicaltrials.gov, the trial initially posted on June 14th 2021 is currently in search of participants. Approximately 100 individuals are sought between 2 sites for this medical study.

Phase < 1

Recruiting

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Willingness and ability to provide informed consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months

Awards & highlights

Study Summary

This trial is measuring the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). Up to 100 cases will be looked at. The Napoleon device will be used to measure the GJA and then compared to visual estimation. A survey will be given to assess the level of ease using Napoleon.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves measurement techniques rather than medication, typical drug side effects are not expected. However, risks may include those generally associated with undergoing an endoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation

Secondary outcome measures

Additional procedure time needed to incorporate use of Napoleon

Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition

Proportion of cases with adverse events or unanticipated problems related to use of Napoleon

+1 more

Trial Design

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,626 Total Patients Enrolled

Brigham and Women's HospitalOTHER

1,615 Previous Clinical Trials

11,470,730 Total Patients Enrolled

Media Library

Roux-en-Y gastric bypass patients with weight regain Clinical Trial Eligibility Overview. Trial Name: NCT04832282 — Phase < 1

Gastric Bypass Research Study Groups: Roux-en-Y gastric bypass patients with weight regain

Gastric Bypass Clinical Trial 2023: Roux-en-Y gastric bypass patients with weight regain Highlights & Side Effects. Trial Name: NCT04832282 — Phase < 1

Roux-en-Y gastric bypass patients with weight regain 2023 Treatment Timeline for Medical Study. Trial Name: NCT04832282 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile compatible with the criteria for this experiment?

"This medical trial requires 100 patients aged 18 to 90 who have undergone bypass or gastric surgery, and meet the additional criteria of being scheduled for an endoscopy, as well as possessing the capacity and willingness to provide informed consent."

Answered by AI

Is the current research trial open to individuals younger than 85 years old?

"As stipulated in the entrance requirements, participants must be 18 or older but cannot exceed 90 years of age."

Answered by AI

Does this medical trial still have open slots for participants?

"According to information on clinicaltrials.gov, this research study is currently accepting candidates into its program. It was originally posted in June 2021 and last modified in May 2022."

Answered by AI

What is the cap on patient enrollment in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial initially posted on June 14th 2021 is currently in search of participants. Approximately 100 individuals are sought between 2 sites for this medical study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Napoleon Measurement of Gastrojejunal Anastomosis

2021. "Napoleon Measurement of Gastrojejunal Anastomosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04832282.

All > Weight Gain > Gastric Bypass