Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects

NCT03831724 | Withdrawn FDA Device

• 1 other identifier: MDT18047
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 will be enrolled at up to 7 clinical sites in the United States. Subjects who meet inclusion and no exclusion criteria and are deemed asymptomatic will be eligible for study enrollment. The procedure visit/s will consist of the following procedures: High resolution manometry (HRM), esophagogastroduodenoscopy (EGD), endolumenal functional lumen imaging probe (EndoFLIP) and a Bravo procedure. A post procedure follow-up phone call will be conducted within 5-9 days of completing all procedures. HRM, EGD, and Bravo procedures are performed to evaluate subjects as normal in addition to being asymptomatic. Abnormal results in one or more of the procedures identifies the subject as unhealthy and the subject will be withdrawn from the study. The expected duration of subject's participation in the study is up to 70 days (up to 30 days from screening to HRM, up to 30 days to complete EGD, EndoFLIP and Bravo, plus 5-9 days for follow up call). Enrollment duration - up to 1 year

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Define and validate normative data of esophago-gastric junction -distensibility index (EGJ-DI) measurements at 60mL in healthy subjects

  Median, 25% and 75% percentile for EGJ-DI measurements at 60mL balloon fill volume

  70 days

Secondary Outcomes (4)

• To define and validate normative data for an EGJ-DI at different balloon fill volumes within the same subject

  70 days

• To define and validate normative data for a maximum restrictive EGJ diameter at different balloon fill volumes within the same subject

  70 days

• To define and validate normative data of a distal esophageal body diameter at different balloon fill volumes within the same subject

  70 days

• To define and validate normative data of contractile patterns at different balloon fill volumes within the same subject

  70 days

Study Arms (1)

EndoFLIP™ System

EXPERIMENTAL

Device interventions included in this arm: HRM, EGD including biopsies, EndoFLIP and Bravo

Device: EndoFLIP™ System with FLIP Topography Module

Interventions

EndoFLIP™ System with FLIP Topography Module DEVICE

The EndoFLIP system with the EF-322N catheter will be used. The EndoFLIP system is a tool that assesses esophageal, esophago-gastric junction (EGJ)/lower esophageal sphincter (LES), and pylorus function. It allows the measurement of LES and pylorus distensibility as well as esophageal contractile activity in response to distension. The system uses impedance planimetry to measure luminal cross-sectional area (CSA) along an axial plane during volume-controlled distention.

EndoFLIP™ System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Officials

• Rena Yadlapati, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: July 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share