EndoFLIP-Guided Initial Management of Esophagogastric Junction Outflow Obstruction
NCT07930143, Not applicable, Not yet recruiting, Hospital Clinic of Barcelona
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | EndoFLIP-Guided Initial Management of Esophagogastric Junction Outflow Obstruction | ClinicalTrials.gov |
| NCT number | NCT07930143 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 115 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hospital Clinic of Barcelona | ClinicalTrials.gov |
| Conditions | Esophagogastric Junction Outflow Obstruction | ClinicalTrials.gov |
| Interventions | EndoFLIP Panometry, Botulinum Toxin Type A (BOTOX) Injection | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Participants With Clinical Response at 3 Months | 3 months after botulinum toxin administration or, for participants initially managed conservatively, 3 months after the index endoscopy. | 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. | ClinicalTrials.gov |
| Secondary | Clinical Response During Follow-up | Months 1, 6, and 12. | Proportion of participants with at least a 50% reduction from baseline in BEDQ total score. | ClinicalTrials.gov |
| Secondary | Change From Baseline in BEDQ Score | Baseline and months 1, 3, 6, and 12. | Change in BEDQ total score from baseline. Scores range from 0 to 40, with higher scores indicating more severe dysphagia. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Eckardt Score | Baseline and months 1, 3, 6, and 12. | Change in Eckardt symptom score from baseline. Scores range from 0 to 12, with higher scores indicating greater symptom burden. | ClinicalTrials.gov |
| Secondary | Sustained Clinical Response | Months 3 through 12. | 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. | ClinicalTrials.gov |
| Secondary | Dysphagia Recurrence After Clinical Response | From the first documented response through month 12. | Proportion of participants with a previously documented clinical response who subsequently have a BEDQ reduction of less than 50% from baseline. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Receiving Definitive EGJ-Directed Treatment | Through month 12. | 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. | ClinicalTrials.gov |
| Secondary | Adverse Events Related to Procedures or Treatment | From the index endoscopy through month 12. | 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 | ClinicalTrials.gov |
| Secondary | Agreement Between Local and Central EndoFLIP Classification | Index endoscopy, with subsequent central review of the same recording. | Agreement on EGJ opening category (reduced, inconclusive, or normal), quantified using Cohen's kappa with a 95% confidence interval. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 17
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 32835840 | BACKGROUND | PubMed |
| 33136563 | BACKGROUND | PubMed |
| 33169488 | BACKGROUND | PubMed |
| 33373111 | BACKGROUND | PubMed |
| 34190376 | BACKGROUND | PubMed |
| 34864928 | BACKGROUND | PubMed |
| 35751633 | BACKGROUND | PubMed |
| 36002925 | BACKGROUND | PubMed |
| 36602829 | BACKGROUND | PubMed |
| 37309619 | BACKGROUND | PubMed |
| 37848686 | BACKGROUND | PubMed |
| 38988105 | BACKGROUND | PubMed |
| 39373501 | BACKGROUND | PubMed |
| 39914779 | BACKGROUND | PubMed |
| 40020937 | BACKGROUND | PubMed |
| 40550032 | BACKGROUND | PubMed |
| 40679455 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)