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Neuromodulation

Enterra Therapy for Nausea and Vomiting (NAVIGATE Trial)

N/A

Recruiting

Research Sponsored by Enterra Medical, Inc.

Eligibility Criteria Checklist

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

Must have

Aged ≥18 years at time of informed consent

Chronic, drug-refractory nausea that: a) has been present for more than 6 months, and b) has been active within the last 3 months prior to consent

Must not have

History of primary psychogenic vomiting

History of primary swallowing disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if the Enterra® Therapy System can help reduce nausea and vomiting symptoms and improve the quality of life for patients with long-term nausea, with or without vomiting, who have normal

Who is the study for?

This trial is for adults over 18 with chronic nausea (with or without vomiting) that's lasted more than 6 months and has been active in the last 3 months. They must have normal gastric emptying, no changes to medical therapy planned, and be medically stable. Participants need a recent normal upper endoscopy and must not respond to two types of antiemetic drugs.

What is being tested?

The NAVIGATE study tests if the Enterra® Therapy System can reduce symptoms of chronic nausea and improve life quality in patients with normal gastric emptying. It involves using this system to see how it affects patients' conditions.

What are the potential side effects?

While specific side effects are not listed here, similar devices may cause discomfort at the implant site, infection risk, device migration or malfunction, which could potentially worsen nausea or lead to other gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have had chronic nausea for over 6 months, active in the last 3 months.

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I have tried at least two types of anti-nausea medications without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of vomiting caused by psychological factors.

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I have a history of difficulty swallowing.

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I have a history of cyclic vomiting syndrome.

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I am on peritoneal dialysis or my hemodialysis is not stable.

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I have a history of organ transplant or certain digestive conditions.

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I have a history of scleroderma.

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I have a history of amyloidosis.

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I have a history of seizures.

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I am receiving nutrition through an IV or feeding tube.

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I have had surgery on my stomach before.

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I use cannabis more than 3 days a week or more than twice a day or over 3 grams a week.

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I have a blockage in my digestive tract.

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I haven't used GLP-1 agonist drugs in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Abdominal Pain Score

Change in Early Satiety Score

Change in Nausea Severity Score

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ON GroupExperimental Treatment1 Intervention

Participants assigned to the ON treatment group will begin with specified device programming values at the randomization visit. Device programming values may be adjusted at follow-up study visits during the blinding period. At the conclusion of the 4-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator. Investigators may adjust programming values at additional follow-up study visits.

Group II: OFF GroupExperimental Treatment1 Intervention

Participants assigned to the OFF treatment group will begin with device programming values set to off at the randomization visit. These settings will continue until the 4-month visit. At the conclusion of the 4-month visit, participants will receive specified device programming values. Device programming values may be adjusted at follow-up study visits. At the conclusion of the 8-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator.

0 / 16Eligibility criteria met