About 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.
Eligibility criteria
Qualifiers
Willing and able to complete the informed consent process
Stated willingness to comply with all study procedures and availability for the duration of the study
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
Disqualifiers
Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements
Pyloric transection therapy completed within 1 year of consent
Documented gastrointestinal (GI) obstruction or pseudo-obstruction
History of primary swallowing disorders
Trial design
Treatments tested in this trial
- Enterra Therapy System
Treatment groups
Sponsors and collaborators
Enterra Medical, Inc.
Lead sponsor
Bright Research Partners
Collaborator