Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT06903806
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet all of the following criteria to be included in the study:
* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
* ASA Classifications 1 and 2.
* For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
* Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. Non-English speakers will not be included in the study because consent forms are in English, and any instructions during exercise will need to be provided in English.
Exclusion Criteria:
Subjects with any of the following conditions or characteristics must be excluded from the study:
* History of any of the following:
* Prior gastric or esophageal surgery, including lap banding or bariatric surgery
* Bowel obstruction
* Gastric outlet obstruction
* Diverticulitis
* Inflammatory bowel disease
* Ileostomy or colostomy
* Gastric or esophageal cancer
* Achalasia
* Esophageal diverticulum
* Active Dysphagia or Odynophagia
* Active medication use for any gastrointestinal conditions
* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
* A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06903806
Study Brief:
Protocol Section:
NCT06903806