Healthy SubjectsRUBYNCT03831724
Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects
A study testing EndoFLIP™ System with FLIP Topography Module in people with Healthy Subjects, run by Medtronic - MITG.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- EndoFLIP™ System with FLIP Topography Module
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
About this study
Official title: Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects ("RUBY Study")
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.
Read more
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
- Being tested
- EndoFLIP™ System with FLIP Topography Module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoFLIP™ System with FLIP Topography ModuleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EndoFLIP™ System | Experimental | Device interventions included in this arm: HRM, EGD including biopsies, EndoFLIP and Bravo Receives: Device: EndoFLIP™ System with FLIP Topography Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 70 days
Secondary outcomes (4)
To define and validate normative data for an EGJ-DI at different balloon fill volumes within the same subject
Mean and median EGJ-DI at different balloon fill volumes of the same subject
Measured: 70 days
To define and validate normative data for a maximum restrictive EGJ diameter at different balloon fill volumes within the same subject
Mean and median maximum restrictive EGJ diameter at different balloon fill volumes of the same subject
Measured: 70 days
To define and validate normative data of a distal esophageal body diameter at different balloon fill volumes within the same subject
Mean and median distal esophageal body diameter at different balloon fill volumes of the same subject
Measured: 70 days
To define and validate normative data of contractile patterns at different balloon fill volumes within the same subject
- Presence of Repetitive antegrade contractions (RACs) and number of antegrade contractions at different balloon fill volumes of the same subject
- Presence of Repetitive Retrograde Contractions (RRCs) and number of retrograde contractions at different balloon fill volumes of the same subject
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study startJul 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Company decision to withdraw the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rena Yadlapati, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831724
- Sponsor's protocol ID
- MDT18047
- Acronym
- RUBY
- Status last verified
- Nov 2019
- First submitted
- 4 Feb 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects ("RUBY Study")
- ClinicalTrials.gov ID
- NCT03831724
- Acronym / sponsor ID
- RUBY / MDT18047
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision to withdraw the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoFLIP™ System | Experimental | Device: EndoFLIP™ System with FLIP Topography ModuleDevice interventions included in this arm: HRM, EGD including biopsies, EndoFLIP and Bravo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoFLIP™ System with FLIP Topography ModuleThe 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. | Device | EndoFLIP™ System |
Primary outcome
Define and validate normative data of esophago-gastric junction -distensibility index (EGJ-DI) measurements at 60mL in healthy subjects
Time frame: 70 days
Median, 25% and 75% percentile for EGJ-DI measurements at 60mL balloon fill volume
4 secondary outcomes
To define and validate normative data for an EGJ-DI at different balloon fill volumes within the same subject
Time frame: 70 days
To define and validate normative data for a maximum restrictive EGJ diameter at different balloon fill volumes within the same subject
Time frame: 70 days
To define and validate normative data of a distal esophageal body diameter at different balloon fill volumes within the same subject
Time frame: 70 days
To define and validate normative data of contractile patterns at different balloon fill volumes within the same subject
Time frame: 70 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rena Yadlapati, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing EndoFLIP™ System with FLIP Topography Module in people with Healthy Subjects, run by Medtronic - MITG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define and validate normative data of esophago-gastric junction -distensibility index (EGJ-DI) measurements at 60mL in healthy subjects (time frame: 70 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.