Dysphagia study: EndoFlip
Official title Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
ClinicalTrials.gov ID: NCT07780981
What this study is testing
- What it's testing
- The study aims to see if the patient’s position (supine vs left side) affects EndoFLIP measurements of the esophagogastric junction.
- Who it's for
- Children and young adults aged 5 and older who have dysphagia, esophageal strictures, achalasia, or other esophageal motility disorders.
- What's involved
- Participants will undergo EndoFLIP testing twice, once lying on their back and once on their left side, with the same device and procedure each time.
- Time commitment
- The study lasts a few hours per visit; each participant will have two short EndoFLIP sessions in different positions during a single appointment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 21
You may be able to join if
- must be between 5 years and 21 years of age at the time of the procedure, which is within the FDA-approved age range for EndoFLIP use.
- participants must be scheduled to undergo a clinically indicated EndoFLIP procedure at Johns Hopkins Children's Center.
- participants must have a parent or legal guardian who is able to provide written informed consent in English, or with the assistance of translation...
- participants who are of appropriate age and developmental capacity must be able to provide assent for study participation.
- participants must be candidates for general anesthesia as determined by the anesthesia team.
You likely can't join if
- patients younger than 5 years of age or 22 years of age and older will be excluded.
- patients who have contraindications to EndoFLIP will be excluded, including situations where upper endoscopy is generally contraindicated such as...
- patients who cannot be safely positioned in both supine and left lateral decubitus positions due to medical or anatomical considerations will be...
- pregnant patients will be excluded. Pregnancy status will be determined by patient or guardian report and, when clinically indicated, by urine or...
- patients whose parent or legal guardian declines to provide informed consent or patients who decline to provide assent when age-appropriate will be...
- patients for whom the proceduralist or anesthesia team determines that participation in the research protocol would pose additional risk beyond...
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.