Enterra Therapy for Nausea and Vomiting

(NAVIGATE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Enterra Medical, Inc.

Must be taking: Antiemetics

Must not be taking: Opioids, GLP-1 agonists

Disqualifiers: Delayed gastric emptying, GI obstruction, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that there are no planned changes to your medical therapy during the study. It's best to discuss your specific medications with the study team.

How is Enterra Therapy different from other treatments for nausea and vomiting?

Enterra Therapy is unique because it involves a surgically implanted device that delivers mild electrical pulses to the stomach nerves, unlike traditional treatments that typically use medications to control nausea and vomiting. ^{1 2 3 4 5}

Research Team

Jason Hamann, PhD

Principal Investigator

Enterra Medical, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum)

I am 18 years old or older.

Exclusion Criteria

History of cannabis hyperemesis syndrome

Pregnant or breastfeeding at the time of consent or intend to become pregnant during the study

Active major levels of anxiety/depression, as determined by the investigator

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants have the Enterra® Therapy System implanted and are assigned to either the ON or OFF treatment group. Device programming values may be adjusted at follow-up study visits.

8 months

Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with adjustments to device programming as needed.

4 months

Treatment Details

Interventions

• Enterra Therapy System (Neuromodulation)

Trial Overview 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.

Participant Groups

Group I: ON Group Experimental Treatment 1 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 Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Enterra Medical, Inc.

Lead Sponsor

Trials

4

Recruited

300+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Findings from Research

Experimental drugs like NK-1 receptor antagonists and 5-HT1A receptor agonists show promise in effectively treating nausea and vomiting associated with cyclic vomiting syndrome, suggesting they target central mechanisms in the brain responsible for these symptoms.

P6 acustimulation is also highlighted as a potential treatment, indicating that both pharmacological and non-pharmacological approaches may be effective in managing nausea and vomiting triggered by various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central mechanisms of vomiting. Miller, AD.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

Central mechanisms of vomiting. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Nausea and vomiting in patients with cancer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Cyclic Vomiting Syndrome. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Antiemetic agents. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Results of a double blind placebo controlled study of ondansetron as an antiemetic during total body irradiation in patients undergoing bone marrow transplantation. [2019]