An interventional study of EndoFLIP Panometry and Botulinum Toxin Type A (BOTOX) Injection in Esophagogastric Junction Outflow Obstruction, sponsored by Hospital Clinic of Barcelona. Not yet recruiting at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment
Esophagogastric junction outflow obstruction (EGJOO) can make it difficult for food to pass from the esophagus into the stomach. Some people improve without a procedure to treat the obstruction, while others have persistent swallowing difficulties and may need further treatment.
The O-FLIP study tests whether measurements taken during an endoscopy with a tool called EndoFLIP can help doctors choose an initial treatment for adults with EGJOO. The main outcome is improvement in swallowing symptoms three months after initial management. The study will also track how long improvement lasts and how many participants need further treatment over one year.
O-FLIP is a prospective, multicenter, nonrandomized, single-arm interventional study evaluating an EndoFLIP-guided initial management strategy for esophagogastric junction outflow obstruction (EGJOO). Specialist esophageal motility units in Spain will enroll consecutive adults with clinically relevant dysphagia who meet the study eligibility criteria. Baseline data will include clinical characteristics, symptom scores, and findings from high-resolution manometry, timed barium esophagram, upper gastrointestinal endoscopy, and EndoFLIP panometry.
Participating centers will receive common training and use a standardized protocol for EndoFLIP acquisition and interpretation based on the Dallas Consensus. The treating endoscopist will interpret EndoFLIP findings in real time to guide initial management. The coordinating center will subsequently review coded recordings to assess measurement quality and agreement with the local classification.
Symptoms and scores on the Brief Esophageal Dysphagia Questionnaire (BEDQ) and Eckardt score will be recorded at 1, 3, 6, and 12 months, along with treatment changes, dysphagia recurrence, adverse events, and treatment escalation. Follow-up will start on the date of botulinum toxin administration for participants who receive it and on the date of the index endoscopy for those initially managed conservatively.
The primary analysis will estimate the proportion of participants with clinical response at 3 months in the overall cohort, with a 95% confidence interval. Outcomes will also be summarized by baseline EndoFLIP category. Secondary analyses will assess the durability of response and time to definitive treatment directed at the esophagogastric junction. Among participants who receive botulinum toxin, exploratory analyses will examine baseline clinical and physiological factors associated with an incomplete or transient response and with subsequent definitive treatment. Additional exploratory analyses will examine how baseline timed barium esophagram findings relate to EndoFLIP findings and clinical outcomes.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 115 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will follow a standardized management algorithm based on esophagogastric junction (EGJ) opening on EndoFLIP panometry. Reduced opening will lead to botulinum toxin type A injection during the same endoscopy. Inconclusive or normal opening will lead to initial conservative management, which may include observation, proton pump inhibitors, neuromodulators, or calcium channel blockers at the treating physician's discretion.
Diagnostic Test: EndoFLIP Panometry · Drug: Botulinum Toxin Type A (BOTOX) Injection
EndoFLIP panometry will be performed during the index upper gastrointestinal endoscopy after mechanical causes of dysphagia have been excluded. The treating endoscopist will classify EGJ opening in real time according to standardized Dallas Consensus criteria. Coded recordings will subsequently undergo central review to assess measurement quality and agreement with the local classification.
Also known as: Functional Lumen Imaging Probe, Impedance Planimetry, FLIP Panometry
Botulinum toxin type A will be injected endoscopically into the lower esophageal sphincter in participants with reduced EGJ opening. The treating physician will be responsible for prescribing and administering the injection as part of the EndoFLIP-guided management strategy.
Also known as: BOTOX
Proportion of Participants With Clinical Response at 3 Months
Proportion of participants in the overall cohort with at least a 50% reduction from baseline in the Brief Esophageal Dysphagia Questionnaire (BEDQ) total score. BEDQ scores range from 0 to 40, with higher scores indicating more severe dysphagia.
Time frame: 3 months after botulinum toxin administration or, for participants initially managed conservatively, 3 months after the index endoscopy.
Clinical Response During Follow-up
Proportion of participants with at least a 50% reduction from baseline in BEDQ total score.
Time frame: Months 1, 6, and 12.
Change From Baseline in BEDQ Score
Change in BEDQ total score from baseline. Scores range from 0 to 40, with higher scores indicating more severe dysphagia.
Time frame: Baseline and months 1, 3, 6, and 12.
Change From Baseline in Eckardt Score
Change in Eckardt symptom score from baseline. Scores range from 0 to 12, with higher scores indicating greater symptom burden.
Time frame: Baseline and months 1, 3, 6, and 12.
Sustained Clinical Response
Proportion of participants with a clinical response at month 3 who maintain at least a 50% reduction from baseline in BEDQ score through month 12 without recurrence.
Time frame: Months 3 through 12.
Dysphagia Recurrence After Clinical Response
Proportion of participants with a previously documented clinical response who subsequently have a BEDQ reduction of less than 50% from baseline.
Time frame: From the first documented response through month 12.
Proportion of Participants Receiving Definitive EGJ-Directed Treatment
Proportion of participants who undergo pneumatic dilation, peroral endoscopic myotomy, or Heller myotomy after initial management, and time from the start of follow-up to the first such treatment.
Time frame: Through month 12.
Adverse Events Related to Procedures or Treatment
Proportion of participants with at least one adverse event associated with endoscopy, EndoFLIP, or treatment. Event severity will be reported using the AGREE classification, from grade I to V
Time frame: From the index endoscopy through month 12.
Agreement Between Local and Central EndoFLIP Classification
Agreement on EGJ opening category (reduced, inconclusive, or normal), quantified using Cohen's kappa with a 95% confidence interval.
Time frame: Index endoscopy, with subsequent central review of the same recording.
Plan to share: No — There is no plan to make individual participant data available to researchers outside the study team. Coded EndoFLIP recordings without direct participant identifiers will be transferred from participating sites to the coordinating center for central review as part of the study. The code key will remain at the originating site.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Botulinum toxin type A
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