Status:
WITHDRAWN
Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects
Lead Sponsor:
Medtronic - MITG
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Multicenter, Prospective, Non-Randomized clinical trial to define and validate normative data of EGJ-distensibility measurements and contractile patterns in healthy subjects. Asymptomatic subjects wi...
Eligibility Criteria
Inclusion
- Healthy male or female ages 18-75 years.
- The subject has the ability to give informed consent.
- The subject has the ability to undergo sedation, as assessed and determined by the treating physician or the anesthesiologist.
- BMI range of 18-30 kg/m2.
- Asymptomatic subjects as assessed by gastro-esophageal reflux disease questionnaire (GERDQ) negative score of less than 8 points (GERDQ \<8) and brief esophageal dysphagia questionnaire (BEDQ) negative score of 0 points (BEDQ score=0), as assessed and determined by treating physician.
Exclusion
- Subject has known or suspected major gastrointestinal motility disorders including but not limited to major esophageal motility disorders, EGJ outflow obstruction and delayed gastric emptying.
- Subject has dysphagia or any swallowing disorder.
- Subject has an inability to tolerate nasal intubation.
- Subject has a known or suspected bleeding diathesis.
- Subject with known or suspected Gastroesophageal Reflux Disease (GERD), or subject has symptoms of GERD.
- The subject has a known or suspected esophageal disease or disorder such as eosinophilic esophagitis (EOE), Barretts esophagus, severe esophagitis, upper GI bleeding or esophageal varices.
- Subject is known or is suspected to suffer from an esophageal stricture or obstruction.
- Subject has a hiatal hernia.
- Subject with medical comorbidities such as diabetes, hypertension hyper/hypothyroidism, or chronic obstructive pulmonary disease (COPD)
- Subject with a diagnosed autoimmune disease.
- Subject who has undergone prior upper GI surgery or interventions such as esophageal myotomy, fundoplication, dilatation or stent.
- Subject has a history of any malignancy.
- Subject has a history of any seizure disorder.
- Subject has a history of an eating disorder/s.
- Subject has an active history of nicotine use, cannabis use or alcohol abuse (as defined by: greater than 14 drinks/week or 4 drinks/day for men, 7 drinks/week or 3 drinks/day for women. A standard drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 oz of liquor). Subject has used any tobacco, nicotine or cannabis products in the last 6 months or has abused alcohol in the last 6 months.
- Subject taking or prescribed or over-the-counter any acid suppressant medications (for example proton-pump inhibitors), any medication that treats reflux or heartburn symptoms (for example Tums and Maalox), any anticoagulant medications, any opiate medication or medication with known impact on GI motility.
- Subject has any allergy or other contraindication to the device components or to study medication used prior and/or during the procedure.
- Subject has a known sensitivity or allergy to nickel or other heavy metals.
- Subject has any condition, which according to the investigators judgment, precludes compliance with study and/or device instructions.
- Females who are pregnant or nursing at the time of screening and/or during the study period or are sexually active and of child bearing potential without medically acceptable methods of contraception.
- Subject who has a cardiac pacemaker or implantable cardiac defibrillator.
- Subject who has a general contraindication for upper endoscopy.
- Subject who is currently participating in another clinical study (investigational drug or device).
- Subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
- Medtronic employees.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03831724
Start Date
July 1 2019
End Date
May 1 2020
Last Update
November 19 2019
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