Normal Esophageal DistensibilityEndoFLIPNCT07754695
Measuring Normal Esophageal Flexibility in Children Using EndoFLIP
A study testing Endoluminal Functional Lumen Imaging Probe (EndoFLIP) in people with Normal Esophageal Distensibility, run by Indiana University.
Trial summary
This study will measure normal esophageal flexibility (distensibility) in children using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP). Children who are already undergoing anesthesia for clinically indicated colonoscopy with colonic motility catheter placement and who have no history or symptoms of… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Esophageal Distensibility
- What is being tested?
- Endoluminal Functional Lumen Imaging Probe (EndoFLIP)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5 to <18 years
- Scheduled to undergo clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia
- No upper gastrointestinal symptoms (including dysphagia, recurrent vomiting, gastroesophageal reflux, or odynophagia)
- No history of esophageal disease or esophageal surgery
- Parent/guardian consent and participant assent, when applicable
Who cannot join
- Known or suspected esophageal pathology
- Prior esophageal surgery or instrumentation
- Anatomic upper gastrointestinal abnormalities
- Contraindication to anesthesia or EndoFLIP catheter placement
About this study
Official title: Prospective Measurement of Normative Esophageal Distensibility Using EndoFLIP in Asymptomatic Children
This study will measure normal esophageal flexibility (distensibility) in children using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP). Children who are already undergoing anesthesia for clinically indicated colonoscopy with colonic motility catheter placement and who have no history or symptoms of esophageal disease will undergo a brief EndoFLIP measurement lasting approximately 3-5 minutes before their scheduled procedure. The information collected will help establish preliminary normal pediatric reference values for esophageal distensibility, which may improve the evaluation of children with esophageal disorders in the future.
Read the detailed description
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared device that measures the size, pressure, and flexibility (distensibility) of the esophagus. In adults, EndoFLIP measurements are routinely used to evaluate esophageal motility disorders such as achalasia. However, normal reference values for children have not been established, and pediatric interpretation currently relies largely on adult data.
The purpose of this prospective, single-center observational study is to generate preliminary normative pediatric EndoFLIP measurements. One hundred children between 5 and younger than 18 years of age who are undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia will be enrolled. Eligible participants must have no history of esophageal disease or surgery and no symptoms suggestive of upper gastrointestinal disease.
Immediately before the scheduled colonoscopy and motility catheter placement, an EndoFLIP catheter will be inserted through the mouth and positioned across the lower esophageal sphincter. Measurements of esophageal diameter, cross-sectional area, pressure, compliance, and distensibility index will be obtained at standardized balloon fill volumes (20-60 mL). The EndoFLIP assessment requires approximately 3-5 minutes and does not require an upper endoscopy or any additional anesthesia. After the measurements are completed, the catheter is removed and the planned clinical procedure proceeds as scheduled. No additional study visits or follow-up are required.
The primary objective is to establish preliminary normative pediatric values for esophageal distensibility and related biomechanical parameters. Secondary analyses will evaluate associations between EndoFLIP measurements and participant age, height, weight, and body mass index. These data are intended to improve interpretation of pediatric EndoFLIP studies and support future research and clinical care for children with esophageal disorders.
- Conditions
- Normal Esophageal Distensibility
- Being tested
- Endoluminal Functional Lumen Imaging Probe (EndoFLIP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoluminal Functional Lumen Imaging Probe (EndoFLIP)Device
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared impedance planimetry device used to measure esophageal diameter, cross-sectional area, intraballoon pressure, distensibility index, and compliance. In this study, the EndoFLIP catheter is inserted orally during general anesthesia immediately before clinically indicated colonoscopy with colonic motility catheter placement. Measurements are obtained over approximately 3-5 minutes at standardized balloon fill volumes of 20-60 mL, after which the catheter is removed and the planned clinical procedure proceeds. The EndoFLIP assessment is performed solely for research purposes to establish preliminary normative pediatric esophageal biomechanical reference values.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Children Undergoing EndoFLIP Assessment | Other | Children 5 to younger than 18 years of age undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia who have no history or symptoms of esophageal disease. Participants undergo a single 3-5 minute EndoFLIP assessment before the scheduled procedure to measure esophageal distensibility index, diameter, cross-sectional area, compliance, and pressure for development of preliminary normative pediatric reference values. Receives: Device: Endoluminal Functional Lumen Imaging Probe (EndoFLIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Distensibility
Esophageal distensibility index measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Measured: During the procedure (approximately 3-5 minutes)
Esophageal Diameter
Esophageal diameter measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Measured: During the procedure (approximately 3-5 minutes)
Esophageal Cross-sectional Area
Esophageal cross-sectional area measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Measured: During the procedure (approximately 3-5 minutes)
Esophageal Compliance
Esophageal compliance measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Measured: During the procedure (approximately 3-5 minutes)
Intraballoon Pressure
Intraballoon pressure measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Measured: During the procedure (approximately 3-5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Esophageal DistensibilityStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Brett J. Hoskins, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754695
- Sponsor's protocol ID
- 28226
- Acronym
- EndoFLIP
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Measurement of Normative Esophageal Distensibility Using EndoFLIP in Asymptomatic Children
- ClinicalTrials.gov ID
- NCT07754695
- Acronym / sponsor ID
- EndoFLIP / 28226
- Conditions
- Normal Esophageal Distensibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Aug 2026 (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.
This study will measure normal esophageal flexibility (distensibility) in children using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP). Children who are already undergoing anesthesia for clinically indicated colonoscopy with colonic motility catheter placement and who have no history or symptoms of esophageal disease will undergo a brief EndoFLIP measurement lasting approximately 3-5 minutes before their scheduled procedure. The information collected will help establish preliminary normal pediatric reference values for esophageal distensibility, which may improve the evaluation of children with esophageal disorders in the future.
Detailed description
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared device that measures the size, pressure, and flexibility (distensibility) of the esophagus. In adults, EndoFLIP measurements are routinely used to evaluate esophageal motility disorders such as achalasia. However, normal reference values for children have not been established, and pediatric interpretation currently relies largely on adult data.
The purpose of this prospective, single-center observational study is to generate preliminary normative pediatric EndoFLIP measurements. One hundred children between 5 and younger than 18 years of age who are undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia will be enrolled. Eligible participants must have no history of esophageal disease or surgery and no symptoms suggestive of upper gastrointestinal disease.
Immediately before the scheduled colonoscopy and motility catheter placement, an EndoFLIP catheter will be inserted through the mouth and positioned across the lower esophageal sphincter. Measurements of esophageal diameter, cross-sectional area, pressure, compliance, and distensibility index will be obtained at standardized balloon fill volumes (20-60 mL). The EndoFLIP assessment requires approximately 3-5 minutes and does not require an upper endoscopy or any additional anesthesia. After the measurements are completed, the catheter is removed and the planned clinical procedure proceeds as scheduled. No additional study visits or follow-up are required.
The primary objective is to establish preliminary normative pediatric values for esophageal distensibility and related biomechanical parameters. Secondary analyses will evaluate associations between EndoFLIP measurements and participant age, height, weight, and body mass index. These data are intended to improve interpretation of pediatric EndoFLIP studies and support future research and clinical care for children with esophageal disorders.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Children Undergoing EndoFLIP Assessment | Other | Device: Endoluminal Functional Lumen Imaging Probe (EndoFLIP)Children 5 to younger than 18 years of age undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia who have no history or symptoms of esophageal disease. Participants undergo a single 3-5 minute EndoFLIP assessment before the scheduled procedure to measure esophageal distensibility index, diameter, cross-sectional area, compliance, and pressure for development of preliminary normative pediatric reference values. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 5 to <18 years
- Scheduled to undergo clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia
- No upper gastrointestinal symptoms (including dysphagia, recurrent vomiting, gastroesophageal reflux, or odynophagia)
- No history of esophageal disease or esophageal surgery
- Parent/guardian consent and participant assent, when applicable
Key exclusion criteria (4 listed)
- Known or suspected esophageal pathology
- Prior esophageal surgery or instrumentation
- Anatomic upper gastrointestinal abnormalities
- Contraindication to anesthesia or EndoFLIP catheter placement
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 |
|---|---|---|
| Endoluminal Functional Lumen Imaging Probe (EndoFLIP)The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared impedance planimetry device used to measure esophageal diameter, cross-sectional area, intraballoon pressure, distensibility index, and compliance. In this study, the EndoFLIP catheter is inserted orally during general anesthesia immediately before clinically indicated colonoscopy with colonic motility catheter placement. Measurements are obtained over approximately 3-5 minutes at standardized balloon fill volumes of 20-60 mL, after which the catheter is removed and the planned clinical procedure proceeds. The EndoFLIP assessment is performed solely for research purposes to establish preliminary normative pediatric esophageal biomechanical reference values. | Device | Asymptomatic Children Undergoing EndoFLIP Assessment |
Primary outcome
Esophageal Distensibility
Time frame: During the procedure (approximately 3-5 minutes)
Esophageal distensibility index measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Esophageal Diameter
Time frame: During the procedure (approximately 3-5 minutes)
Esophageal diameter measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Esophageal Cross-sectional Area
Time frame: During the procedure (approximately 3-5 minutes)
Esophageal cross-sectional area measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Esophageal Compliance
Time frame: During the procedure (approximately 3-5 minutes)
Esophageal compliance measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Intraballoon Pressure
Time frame: During the procedure (approximately 3-5 minutes)
Intraballoon pressure measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endoluminal Functional Lumen Imaging Probe (EndoFLIP) in people with Normal Esophageal Distensibility, run by Indiana University.
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 4 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: opening soon, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Esophageal Distensibility (time frame: During the procedure (approximately 3-5 minutes)). The study lists 5 primary outcomes in all. 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 8 Sep 2026.