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nVNS (gammaCore) for Gastroparesis-Related Nausea (nVNS Trial)
nVNS Trial Summary
This trial is testing whether a handheld device that sends electrical stimulation to the vagus nerve can relieve nausea, with the goal of providing a safer alternative to traditional rescue medications.
nVNS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belownVNS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.nVNS Trial Design
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- You can take ondansetron, promethazine or prochlorperazine for nausea/vomiting, but not more than four times a day.You are allowed to take ondansetron, promethazine, or prochlorperazine up to four times a day as needed.You have ongoing moderate to severe nausea, vomiting, bloating, or abdominal pain.You have conditions like blockages in your intestines or uncontrolled esophagitis that are causing symptoms, and these have been confirmed by standard tests like X-rays or endoscopies.You have ongoing moderate to severe nausea, vomiting, bloating, or abdominal pain.You have symptoms that could be caused by a blockage in your digestive system or other stomach-related issues that are not under control.You have another health condition that could be causing your symptoms, according to the doctor.You have had surgery on your upper digestive system, like the stomach or esophagus, including vagotomy.You use strong pain medications more than three days a week.You have a history of heart rhythm problems.Your initial ECG shows certain irregular heartbeats or rhythms.You have had surgery on the right side of your neck's blood vessels.You have metal implants in your neck or near the area where the gammaCore device is used.You have been diagnosed with gastroparesis or chronic unexplained nausea and vomiting.You have had surgery to cut the nerves in your neck.Your high blood pressure is not under control.You currently have a device implanted in your body that sends electrical signals, like a pacemaker or neurostimulator.You have been diagnosed with gastroparesis or chronic unexplained nausea and vomiting.You are currently experiencing moderate to severe nausea and other stomach-related symptoms.You are currently experiencing moderate to severe nausea, vomiting, bloating, or abdominal pain.
- Group 1: nVNS device
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people fit the qualifications for this research project?
"That is accurate. The clinical trial, which was posted on 4/19/2021 and last updated on 3/8/2022, is still recruiting patients. Up to 45 participants are needed from 1 site."
Are we enrolling people in this experiment at the moment?
"That is right, the online information from clinicaltrials.gov states that this research study is still looking for participants. The posting went up on April 19th 2021 and was updated as recently as March 8th of this year. So far, only 45 individuals have signed up at a single location."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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